REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes
Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02320253
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
211
4
3
80
52.8
0.7
Study Details
Study Description
Brief Summary
The goal of this project is to translate the Look AHEAD intensive lifestyle intervention for type 2 diabetes and obesity into usual care at community health centers, comparing an in-person group program (IP), a telephone conference call (TCC) group program, and referral to medical nutrition therapy (MNT), the current standard of care.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Participants will be randomly assigned to one of three arms: MNT, IP, or TCC. Participants will be enrolled in the study for a total of three years. During those three years, participants will have 5 research visits, at baseline, where randomization occurs, 6 months, 12 months, 24 months, and 36 months. At each research visit, participants will have a lipid panel and HbA1c sample drawn, their blood pressure, weight, and height, baseline only, taken. Participants will also answer questionnaires that will address health behaviors, self-efficacy, measures of self-determination, depression, literacy and numeracy, food insecurity, health-related quality-of-life and patient satisfaction with quality of care.
For the group-based interventions, dietitians will deliver the adapted Look AHEAD lifestyle intervention. The first 14 sessions will be delivered weekly and the next 5 sessions biweekly. In the subsequent 18 months, group sessions will be delivered monthly from 6-24 months. In addition, participants will be offered up to 5 individual MNT sessions over the 2 year intervention period. At these individual visits, dietitians will address diabetes-related issues and discuss tailored goals and behaviors, based on the Look AHEAD model. Dietitians will provide ongoing feedback to participants' own PCPs about patient progress toward goals and will encourage PCPs to reinforce weight loss strategies with their patients. Each group will contain up to 12 participants with type 2 diabetes and will last 1-1.5 hours. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success.
In addition to the teaching component, participants who are taking insulin or medications that can cause hypoglycemia will self-monitor blood glucose levels at least 2 times per day and submit self-monitoring records for review each week, either by delivering them at the in-person sessions or by mailing, faxing, or emailing them to the study team. Patients on oral hypoglycemics who are not adjusting medications based on blood sugar will be instructed to do targeted monitoring to determine the effects of exercise and meals on blood glucose. The study provider at each health center will review BG records and make any needed adjustments to insulin or medication doses according to an algorithm to maintain glycemic control and prevent hypoglycemia as participants lose weight.
A trained member of the study staff will provide MNT referral participants with an educational handout emphasizing that modest weight loss (5 - 10%) via caloric restriction and gradual adoption of moderate increases in daily physical activity (equivalent to brisk walking for 30 minutes daily) is safe and effective in managing diabetes and schedule them for an appointment with a dietitian from Nutrition Services for follow up.
Study Design
Study Type:
Interventional
Actual Enrollment
:
211 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
REAL HEALTH-Diabetes: Reach Ahead for Lifestyle and Health-Diabetes
Study Start Date
:
Nov 1, 2014
Actual Primary Completion Date
:
Sep 1, 2020
Actual Study Completion Date
:
Jul 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Medical Nutrition Therapy (MNT) Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s). |
Behavioral: Medical Nutrition Therapy (MNT)
Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year.
|
| Experimental: In Person Group (IP) Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. |
Behavioral: In Person Group (IP)
The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success.
|
| Experimental: Telephone Conference Call Group (TCC) Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. |
Behavioral: Telephone Conference Call Group (TCC)
The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention.
|
Outcome Measures
Primary Outcome Measures
- Percent Weight Change From Baseline [Baseline, 6, 12, 24, and 36 months.]
Percent weight change form baseline; negative values indicate weight loss.
Secondary Outcome Measures
- Hemoglobin A1c: Change From Baseline [6, 12, 24 months]
Change in percentage of glycated hemoglobin. Negative values indicate HbA1c reduction (improvement) from baseline.
- Systolic Blood Pressure: Change From Baseline [6, 12, 24, months.]
Blood pressure is reported as change in systolic blood pressure only. Negative values indicate improvement.
- Triglyceride Levels: Change From Baseline [6, 12, 24 months]
Triglycerides are measured in mg/dl. Negative values indicate improved triglyceride levels compared to baseline.
- Diet Self-efficacy: Change From Baseline [6, 12, 24, and 36 months.]
Diet Self-Efficacy Scale is scored 1-5 with higher scores denoting greater self confidence in managing diet and positive values denoting improved self-confidence in managing diet. Hickey ML, Owen SV, Froman RD. Instrument development: cardiac diet and exercise self-efficacy. Nursing research. 1992;41(6):347-351
- Fat-related Diet Behavior: Change From Baseline. [Baseline, 6, 12, 24, and 36 months.]
Fat-related diet behavior was scored on a scale of 1 to 5, in which lower scores indicate lower fat dietary habits. Negative values indicate a shift to lower-fat diet behavior. Kristal AR, Shattuck AL, Henry HJ. Patterns of dietary behavior associated with selecting diets low in fat: reliability and validity of a behavioral approach to dietary assessment. J Am Diet Assoc. 1990;90(2):214-220. Glasgow RE, Perry JD, Toobert DJ, Hollis JF. Brief assessments of dietary behavior in field settings. Addictive behaviors. 1996;21(2):239-247
- Dietary Restraint: Change From Baseline [Baseline, 6, 12, 24, and 36 months.]
Dietary restraint was measured by the Dutch Eating Behavior Questionnaire with higher scores (1-5) denoting greater self-regulation of dietary behaviors and positive values denoting improved dietary restraint. Van Strien T, Frijters JER, Defares PB. The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional, and external eating behavior. International Journal of Eating Disorders. 1986;5(2):295-315.
- Diabetes Distress: Change From Baseline [Baseline, 6, 12, 24, and 36 months.]
Diabetes distress was measured with the Problem Areas in Diabetes Scale. The scale ranges from 0 to 100, in which higher scores indicate greater emotional distress, with a score of 40 marking the threshold for severe emotional distress. Negative values indicate reduction in diabetes-related distress. Welch GW, Jacobson AM, Polonsky WH. The Problem Areas in Diabetes Scale. An evaluation of its clinical utility. Diabetes Care. 1997;20(5):760-766
- Depression Score: Change From Baseline. [Baseline, 6, 12, 24, and 36 months.]
The PHQ-8 measures depressed mood, with higher scores representing a higher degree of depressed mood and negative values indicating improvement. The range of scores is 0 to 24. Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009;114(1-3):163-173.
Other Outcome Measures
- Health Economics [12 months]
Total cost of intervention at 12 months taking into account intervention cost and savings from medication dose reduction. Incremental cost effectiveness and probabilistic sensitivity analyses and further details are reported in: Delahanty LM, Levy DE, Chang Y, Porneala BC, Goldman V, McCarthy J, Bissett L, Rodriguez AR, Chase B, LaRocca R, Wheeler A, Wexler DJ. Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinical Trial. J Gen Intern Med. 2020 Sep;35(9):2637-2646. doi: 10.1007/s11606-019-05629-9. Epub 2020 Jan 21. PMID: 31965526; PMCID: PMC7458982.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Diagnosis of type 2 diabetes
-
Age 18 years or older
-
Overweight or obese (BMI >25 kg/m2)
-
HbA1c level 6.5<11.5%
-
Systolic blood pressure (SBP) <160 mmHg, diastolic blood pressure (DBP) <100 mmHg
-
Willing to lose 5-7% of body weight
-
Willing to increase activity to at least 175 minutes/week
-
Willing to commit to random assignment to either attend and participate in the lifestyle change program in person or on the telephone or be referred to Nutrition Services for medical nutrition therapy
-
Stable health, with no severe comorbidities that might interfere with their ability to participate in a group intervention that includes increasing activity or decreasing calories, such as severe psychiatric illness or significant heart disease
-
Ability to understand and communicate effectively in English or Spanish
-
Willing to self-monitor blood glucose
-
Willing to keep a food, exercise, and blood glucose diary
-
Have a primary care physician at MGH Chelsea, Charlestown, or Revere Health Centers, or be willing to attend sessions, in-person or by phone, and have medications adjusted by a provider based at one of those health centers with communication to the referring primary care provider
Exclusion Criteria:
-
Weight greater than 350 pounds
-
Pregnant or planning pregnancy in the next year
-
Currently seeing a dietitian (regular scheduled follow up appointments) or participating in a weight loss program and unwilling to stop
-
Weight change of more than 3% of weight in the previous month.
-
Currently enrolled in another diabetes intervention study
-
Lack of availability of telephone
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 2 | Charlestown HealthCare Center | Charlestown | Massachusetts | United States | 02129 |
| 3 | Chelsea HealthCare Center | Chelsea | Massachusetts | United States | 02150 |
| 4 | Revere HealthCare Center | Revere | Massachusetts | United States | 02151 |
Sponsors and Collaborators
- Massachusetts General Hospital
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Linda M Delahanty, MS RD, Massachusetts General Hospital
- Principal Investigator: Deborah J Wexler, MSc MD, Massachusetts General Hospital
Study Documents (Full-Text)
More Information
Publications
Responsible Party:
Linda M. Delahanty,
Chief Dietitian at Massachusetts General Hospital Diabetes Center,
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02320253
Other Study ID Numbers:
- 2014P002074
- 1R18DK102737-01A1
First Posted:
Dec 19, 2014
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021
Keywords provided by Linda M. Delahanty,
Chief Dietitian at Massachusetts General Hospital Diabetes Center,
Massachusetts General Hospital
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Actual enrollment 211 |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) |
|---|---|---|---|
| Arm/Group Description | Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s). Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year. | Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. | Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention. |
| Period Title: Overall Study | |||
| STARTED | 69 | 70 | 72 |
| COMPLETED | 63 | 68 | 70 |
| NOT COMPLETED | 6 | 2 | 2 |
Baseline Characteristics
| Arm/Group Title | Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s). Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year. | Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. | Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention. | Total of all reporting groups |
| Overall Participants | 66 | 70 | 72 | 208 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
61.4
(10.7)
|
61.3
(10.3)
|
62.4
(9.8)
|
61.7
(10.2)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
37
56.1%
|
37
52.9%
|
41
56.9%
|
115
55.3%
|
| Male |
29
43.9%
|
33
47.1%
|
31
43.1%
|
93
44.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
11
16.7%
|
10
14.3%
|
7
9.7%
|
28
13.5%
|
| Not Hispanic or Latino |
55
83.3%
|
60
85.7%
|
65
90.3%
|
180
86.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
3%
|
3
4.3%
|
2
2.8%
|
7
3.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
5
7.6%
|
2
2.9%
|
2
2.8%
|
9
4.3%
|
| White |
47
71.2%
|
55
78.6%
|
58
80.6%
|
160
76.9%
|
| More than one race |
12
18.2%
|
10
14.3%
|
10
13.9%
|
32
15.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | ||||
| United States |
66
100%
|
70
100%
|
72
100%
|
208
100%
|
| Weight (kg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [kg] |
99.7
(21.4)
|
98.8
(17.0)
|
96.1
(18.2)
|
98.7
(18.9)
|
| Hemoglobin A1c (Percentage of glycated hemoglobin) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Percentage of glycated hemoglobin] |
7.8
(1.2)
|
7.8
(1.2)
|
7.6
(1.1)
|
7.7
(1.2)
|
| Systolic blood pressure (mmHg) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mmHg] |
125
(16)
|
126
(14)
|
124
(10)
|
125
(14)
|
| Triglycerides (mg/dl) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [mg/dl] |
146
(99)
|
196
(290)
|
152
(94)
|
165
(186)
|
| Diet self efficacy scale (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
3.7
(0.6)
|
3.6
(0.7)
|
3.8
(0.7)
|
3.7
(0.7)
|
| Fat-related diet behavior (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
2.7
(0.6)
|
2.7
(0.5)
|
2.8
(0.6)
|
2.7
(0.6)
|
| Dietary restraint (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
2.8
(0.6)
|
2.9
(0.6)
|
2.8
(0.8)
|
2.8
(0.7)
|
| Diabetes Distress (score) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [score] |
36.9
(23.1)
|
39.3
(19.5)
|
40.3
(23.3)
|
38.9
(22.0)
|
| Mood (units on a scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on a scale] |
5.3
(5.4)
|
4.7
(4.4)
|
4.4
(3.8)
|
4.8
(4.6)
|
Outcome Measures
| Title | Percent Weight Change From Baseline |
|---|---|
| Description | Percent weight change form baseline; negative values indicate weight loss. |
| Time Frame | Baseline, 6, 12, 24, and 36 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) |
|---|---|---|---|
| Arm/Group Description | Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s). Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year. | Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. | Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention. |
| Measure Participants | 63 | 68 | 70 |
| Six months |
-1.1
(3.7)
|
-5.6
(4.9)
|
-4.6
(5.8)
|
| Twelve months |
-2.0
(4.1)
|
-4.5
(6.1)
|
-4.8
(6.1)
|
| Twenty-four months |
-3.1
(5.2)
|
-4.4
(5.9)
|
-4.0
(5.8)
|
| Thirty-six months |
-5.8
(7.1)
|
-4.4
(5.4)
|
-5.3
(6.4)
|
| Title | Hemoglobin A1c: Change From Baseline |
|---|---|
| Description | Change in percentage of glycated hemoglobin. Negative values indicate HbA1c reduction (improvement) from baseline. |
| Time Frame | 6, 12, 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) |
|---|---|---|---|
| Arm/Group Description | Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s). Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year. | Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. | Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention. |
| Measure Participants | 65 | 68 | 70 |
| Six months |
-0.3
(1.1)
|
-0.6
(0.8)
|
-0.5
(1.2)
|
| Twelve months |
-0.4
(1.2)
|
-0.4
(0.8)
|
-0.2
(1.3)
|
| Twenty-four months |
-0.2
(1.4)
|
-0.3
(1.3)
|
0.1
(1.4)
|
| Title | Systolic Blood Pressure: Change From Baseline |
|---|---|
| Description | Blood pressure is reported as change in systolic blood pressure only. Negative values indicate improvement. |
| Time Frame | 6, 12, 24, months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) |
|---|---|---|---|
| Arm/Group Description | Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s). Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year. | Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. | Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention. |
| Measure Participants | 66 | 68 | 70 |
| Six months |
0
(14.7)
|
-4.0
(15)
|
-2.3
(14)
|
| Twelve months |
1.8
(16)
|
-1.8
(16)
|
-1.0
(15)
|
| Twenty-four months |
-0.6
(16)
|
-3.5
(15)
|
-3.3
(15)
|
| Title | Triglyceride Levels: Change From Baseline |
|---|---|
| Description | Triglycerides are measured in mg/dl. Negative values indicate improved triglyceride levels compared to baseline. |
| Time Frame | 6, 12, 24 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) |
|---|---|---|---|
| Arm/Group Description | Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s). Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year. | Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. | Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention. |
| Measure Participants | 61 | 66 | 70 |
| Six months |
12.5
(80)
|
-56.0
(253)
|
-21.3
(81)
|
| Twelve months |
7.9
(76)
|
-57.4
(259)
|
-1.1
(114)
|
| Twenty-four months |
-8.6
(71)
|
-31.8
(228)
|
-4.1
(86)
|
| Title | Diet Self-efficacy: Change From Baseline |
|---|---|
| Description | Diet Self-Efficacy Scale is scored 1-5 with higher scores denoting greater self confidence in managing diet and positive values denoting improved self-confidence in managing diet. Hickey ML, Owen SV, Froman RD. Instrument development: cardiac diet and exercise self-efficacy. Nursing research. 1992;41(6):347-351 |
| Time Frame | 6, 12, 24, and 36 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) |
|---|---|---|---|
| Arm/Group Description | Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s). Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year. | Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. | Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention. |
| Measure Participants | 51 | 61 | 58 |
| Six months |
-0.2
(0.7)
|
0.3
(0.7)
|
0.1
(0.6)
|
| Twelve months |
-0.3
(0.8)
|
0.2
(0.8)
|
-0.1
(0.8)
|
| Twenty-four months |
-0.2
(0.8)
|
0.3
(0.7)
|
-0.1
(0.8)
|
| Thirty-six months |
-0.1
(0.9)
|
-0.1
(0.9)
|
-0.4
(0.8)
|
| Title | Fat-related Diet Behavior: Change From Baseline. |
|---|---|
| Description | Fat-related diet behavior was scored on a scale of 1 to 5, in which lower scores indicate lower fat dietary habits. Negative values indicate a shift to lower-fat diet behavior. Kristal AR, Shattuck AL, Henry HJ. Patterns of dietary behavior associated with selecting diets low in fat: reliability and validity of a behavioral approach to dietary assessment. J Am Diet Assoc. 1990;90(2):214-220. Glasgow RE, Perry JD, Toobert DJ, Hollis JF. Brief assessments of dietary behavior in field settings. Addictive behaviors. 1996;21(2):239-247 |
| Time Frame | Baseline, 6, 12, 24, and 36 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) |
|---|---|---|---|
| Arm/Group Description | Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s). Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year. | Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. | Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention. |
| Measure Participants | 53 | 62 | 59 |
| Six months |
-0.1
(0.4)
|
-0.4
(0.5)
|
-0.3
(0.5)
|
| Twelve months |
-0.2
(0.4)
|
-0.4
(0.5)
|
-0.3
(0.5)
|
| Twenty-four months |
-0.2
(0.4)
|
-0.4
(0.4)
|
-0.4
(0.5)
|
| Thirty-six months |
-0.3
(0.5)
|
-0.3
(0.4)
|
-0.3
(0.4)
|
| Title | Dietary Restraint: Change From Baseline |
|---|---|
| Description | Dietary restraint was measured by the Dutch Eating Behavior Questionnaire with higher scores (1-5) denoting greater self-regulation of dietary behaviors and positive values denoting improved dietary restraint. Van Strien T, Frijters JER, Defares PB. The Dutch Eating Behavior Questionnaire (DEBQ) for assessment of restrained, emotional, and external eating behavior. International Journal of Eating Disorders. 1986;5(2):295-315. |
| Time Frame | Baseline, 6, 12, 24, and 36 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) |
|---|---|---|---|
| Arm/Group Description | Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s). Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year. | Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. | Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention. |
| Measure Participants | 54 | 62 | 59 |
| Six months |
0.4
(0.7)
|
0.6
(0.6)
|
0.6
(0.7)
|
| Twelve months |
0.5
(0.7)
|
0.5
(0.6)
|
0.5
(0.7)
|
| Twenty-four months |
0.3
(0.7)
|
0.7
(0.7)
|
0.6
(0.6)
|
| Thirty six months |
0.4
(0.4)
|
0.7
(0.7)
|
0.4
(0.8)
|
| Title | Diabetes Distress: Change From Baseline |
|---|---|
| Description | Diabetes distress was measured with the Problem Areas in Diabetes Scale. The scale ranges from 0 to 100, in which higher scores indicate greater emotional distress, with a score of 40 marking the threshold for severe emotional distress. Negative values indicate reduction in diabetes-related distress. Welch GW, Jacobson AM, Polonsky WH. The Problem Areas in Diabetes Scale. An evaluation of its clinical utility. Diabetes Care. 1997;20(5):760-766 |
| Time Frame | Baseline, 6, 12, 24, and 36 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) |
|---|---|---|---|
| Arm/Group Description | Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s). Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year. | Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. | Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention. |
| Measure Participants | 54 | 62 | 59 |
| Six months |
-7.0
(17.6)
|
-12.4
(20.3)
|
-14.1
(19.4)
|
| Twelve months |
-5.8
(18)
|
-14.4
(15)
|
-15.1
(21.9)
|
| Twenty-four months |
-9.2
(22.8)
|
-13.0
(15.3)
|
-16.3
(20)
|
| Thirty-six months |
-13.4
(22.9)
|
-14.1
(17.8)
|
-14.3
(18.6)
|
| Title | Depression Score: Change From Baseline. |
|---|---|
| Description | The PHQ-8 measures depressed mood, with higher scores representing a higher degree of depressed mood and negative values indicating improvement. The range of scores is 0 to 24. Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009;114(1-3):163-173. |
| Time Frame | Baseline, 6, 12, 24, and 36 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) |
|---|---|---|---|
| Arm/Group Description | Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s). Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year. | Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. | Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention. |
| Measure Participants | 53 | 62 | 57 |
| Six months |
-0.6
(4.5)
|
-1.0
(3.3)
|
-0.7
(3.1)
|
| Twelve months |
-0.9
(4.1)
|
-1.2
(2.8)
|
-0.4
(3.7)
|
| Twenty-four months |
-1.0
(4.3)
|
-0.8
(3.2)
|
-0.1
(3.1)
|
| Thirty-six months |
-0.9
(5.2)
|
-0.7
(3.7)
|
0.2
(4.3)
|
| Title | Health Economics |
|---|---|
| Description | Total cost of intervention at 12 months taking into account intervention cost and savings from medication dose reduction. Incremental cost effectiveness and probabilistic sensitivity analyses and further details are reported in: Delahanty LM, Levy DE, Chang Y, Porneala BC, Goldman V, McCarthy J, Bissett L, Rodriguez AR, Chase B, LaRocca R, Wheeler A, Wexler DJ. Effectiveness of Lifestyle Intervention for Type 2 Diabetes in Primary Care: the REAL HEALTH-Diabetes Randomized Clinical Trial. J Gen Intern Med. 2020 Sep;35(9):2637-2646. doi: 10.1007/s11606-019-05629-9. Epub 2020 Jan 21. PMID: 31965526; PMCID: PMC7458982. |
| Time Frame | 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) |
|---|---|---|---|
| Arm/Group Description | Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s). Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year. | Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. | Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention. |
| Measure Participants | 64 | 69 | 70 |
| Mean (95% Confidence Interval) [US Dollar] |
591
|
1390
|
1814
|
Adverse Events
| Time Frame | 3 years | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | SAEs were collected according to standard definitions (hospitalized events, death, etc). Other Adverse events were not monitored/addressed in this lifestyle intervention study. | |||||
| Arm/Group Title | Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) | |||
| Arm/Group Description | Participants in this arm will meet with a dietitian at their respective Health Center, not with a study dietitian. The participant and dietitian will decide how frequently to meet and create an individualized treatment plan. The participant's health insurance will be billed for these dietitian visit(s) and the participant is responsible for any copay(s) or deductible(s) associated with the visit(s). Medical Nutrition Therapy (MNT): Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year. | Participants enrolled to the IP arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. In Person Group (IP): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. | Participants enrolled in the TCC arm will meet weekly for 14 weeks, biweekly for 10 weeks, and then monthly for the next 18 months. Each session will be led, over-the-phone, by a study dietitian that has been assigned to that specific health center and will last 1.5 hours. Participants will be allowed to have one-on-one sessions with their dietitian throughout the first two years, twice in the first year and three times in the second year. Telephone Conference Call Group (TCC): The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention. | |||
All Cause Mortality |
||||||
| Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/66 (1.5%) | 0/70 (0%) | 1/72 (1.4%) | |||
Serious Adverse Events |
||||||
| Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 18/66 (27.3%) | 16/70 (22.9%) | 12/72 (16.7%) | |||
| General disorders | ||||||
| Hospital admission | 18/66 (27.3%) | 25 | 16/70 (22.9%) | 17 | 12/72 (16.7%) | 16 |
Other (Not Including Serious) Adverse Events |
||||||
| Medical Nutrition Therapy (MNT) | In Person Group (IP) | Telephone Conference Call Group (TCC) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/0 (NaN) | 0/0 (NaN) | 0/0 (NaN) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Deborah J. Wexler |
|---|---|
| Organization | MGH Diabetes Center |
| Phone | 617-726-8767 |
| dwexler@mgh.harvard.edu |
Responsible Party:
Linda M. Delahanty,
Chief Dietitian at Massachusetts General Hospital Diabetes Center,
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02320253
Other Study ID Numbers:
- 2014P002074
- 1R18DK102737-01A1
First Posted:
Dec 19, 2014
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021