CTL: Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice - Choose to Lose

Sponsor

Memorial Hospital of Rhode Island (Other)

Overall Status

Completed

CT.gov ID

NCT01542671

Collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)

200

Enrollment

Location

Arms

69.9

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study is to evaluate the effectiveness of tailored lifestyle intervention in primary care by comparing changes in the primary measure of weight and body mass index (BMI) and secondarily: physical activity (PA), fat calories consumed, and fruit/vegetable servings within the two arms (intervention and control) of the study. It is hypothesized that the intervention cohort will demonstrate greater reductions in body weight, body neglect, and fat calories consumed and greater increases in physical activity and fruits/vegetable servings after two years compared to the control cohort. The study also aims to evaluate and compare the cost of intervention for purpose per each unit of measure lost between the two arms of the study as a secondary objective. The cost of intervention will be evaluated as it relates to study replication.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Behavioral: Intervention Behavioral: Control	N/A

Detailed Description

The study will translate and evaluate previously successful weight loss and physical activity studies into a primary care setting in terms of efficacy and cost effectiveness. Patients are recruited by their primary care physicians office and screened for participation and contraindications by phone. A screening visit with a run-in period of food and exercise log adherence is performed. All participants have meetings with a Lifestyle Counselor to set nutritional and lifestyle goals and an introduction to weight loss techniques at baseline, 6 months, and 12 months. A structured eating plan will be given at the baseline visit. Participants at the baseline visit are randomized to either the intervention and control groups. During the first year, intervention participants will receive monthly motivational phone calls from their lifestyle counselor to assess their progress and help navigate the lifestyle changes. Food and exercise logs are reviewed frequently and written feedback give to each interventional participant. Intervention participants also receive weekly mailings focusing on weight loss, physical activity and healthy eating, and four tailored mailings based upon information gained through contact with the lifestyle counselor. Intervention participants will also receive 2 informative DVDs during the first year. Control participants receive 2 NIDDK informational handouts on weight loss. For the second year of the study focuses on maintenance. Intervention participants receive reduced mailings of 2 per month for 6 months and then once a month until the end of one year. Intervention participants receive one additional motivational phone call at 13 months if they have not reached their weight loss goal and also receive 2 more informative DVDs. The control participants will receive 3 informational NIDDK mailings. The two arms of the study will be compared using the critical outcome measures (weight loss, PA, fat calories & vegetable/fruit servings consumed) and secondary outcome measures (waist and hip circumference,BP,Heart rate) for weight loss efficacy. We will also evaluate the cost-effectiveness for dissemination as a PCP weight loss program in addition to the overall cost-effectiveness for the participant in terms of money spent and adverse events related to the lifestyle change.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Tailored Lifestyle Intervention in Obese Adults Within Primary Care Practice

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Lifestyle counseling at baseline, six, twelve months; Food and exercise log recording and feedback, motivational phone calls monthly for 12 months, 4 tailored mailings on lifestyle change, and weekly mailings on weight loss, exercise, and healthy eating for first 12 months. Maintenance mailings biweekly for six months and then monthly during the second year.	Behavioral: Intervention Lifestyle Counselor meetings at baseline, 6 months, and 12 months Structured eating plan Tailored nutritional and exercise tips. Weekly: months 1-12, biweekly: months 13-18, and monthly: months 19-24. Monthly Motivational phone calls with Lifestyle Counselor for the first year 4 informational DVDs over the two year period Feedback on submitted food and exercise journals
Placebo Comparator: Control Lifestyle counseling at baseline, six and twelve months similar to intervention group, and infrequent non-tailored pamphlets.	Behavioral: Control Lifestyle Counselor meetings at baseline, 6 months, and 12 months Structured eating plan 5 informational NIDDK mailings over the two year period

Arm

Intervention/Treatment

Experimental: Intervention

Lifestyle counseling at baseline, six, twelve months; Food and exercise log recording and feedback, motivational phone calls monthly for 12 months, 4 tailored mailings on lifestyle change, and weekly mailings on weight loss, exercise, and healthy eating for first 12 months. Maintenance mailings biweekly for six months and then monthly during the second year.

Behavioral: Intervention

Lifestyle Counselor meetings at baseline, 6 months, and 12 months Structured eating plan Tailored nutritional and exercise tips. Weekly: months 1-12, biweekly: months 13-18, and monthly: months 19-24. Monthly Motivational phone calls with Lifestyle Counselor for the first year 4 informational DVDs over the two year period Feedback on submitted food and exercise journals

Placebo Comparator: Control

Lifestyle counseling at baseline, six and twelve months similar to intervention group, and infrequent non-tailored pamphlets.

Behavioral: Control

Lifestyle Counselor meetings at baseline, 6 months, and 12 months Structured eating plan 5 informational NIDDK mailings over the two year period

Outcome Measures

Primary Outcome Measures

Changes in Body Weight & Physical Activity [Five years]
The primary outcomes of the trial are measured changes in BMI and physical activity level.

Secondary Outcome Measures

Cost Effectiveness [Five Years]
Secondary outcomes are cost effectiveness of the intervention as measured by cost per unit of BMI loss. Additional outcomes are changes in stages of change, decision balance, self-efficacy, and problem solving skills during the trial.
Eating Behaviors [5 years]
Eating behaviors (measured as servings of fruits/vegtables and fat calories consumed) as self reported, Diet History Questionnaire II, SF-12, Eating Behavior Inventory, Three Factor Eating, and General Self Efficacy questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Male/female ≥18 and <80 years old
Available for this research project for the entire 24-month study period
Able to read and speak English
Can provide informed consent

Exclusion Criteria:

Diagnosed or hospitalization for active CVD disease in the past 6 months including: CHD or history of coronary revascularization procedure (e.g. angioplasty, bypass graft surgery), Stroke, Peripheral Vascular Disease, Heart Failure, Deep Vein Thrombosis (DVT)
Unstable psychiatric condition
History of a significant orthopedic limitation or other conditions that make exercise dangerous or extremely difficult
Limited physical activity by a physician to less than a brisk walk
Another family member in the study
Limited prescribed diet (e.g. gluten free diet)
Present treatment for an eating disorder
Underwent treatment for cancer in the past 5 years
Dialysis
Poorly controlled diabetes (HgbA1c > 10) or hospitalized in past 6 months for poorly controlled diabetes
Chronic steroid therapy
Participant requesting surgical treatment of obesity or weighing over 400 lbs.
Major surgery in the past month
Participating in another clinical trial with regards to obesity or physical activity