MAINTAIN-PC: Computer-Based Weight Maintenance in Primary Care

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT01946191
• Collaborator: Agency for Healthcare Research and Quality (AHRQ) (U.S. Fed)
• Enrollment: 194
• Location: 1
• Arms: 2
• Actual Duration (Months): 47.1
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief Summary

This randomized trial tested the hypothesis that there would be an incremental benefit of personalized coaching and PCP support in an EHR-based intervention designed to help primary care patients maintain recent intentional weight loss of at least 5%.

Condition or Disease	Intervention/Treatment	Phase
Body Weight; Weight Loss; Motor Activity	Behavioral: 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts.; Behavioral: Online self-monitoring; Behavioral: Real-time updates to Primary Care physicians	N/A

Detailed Description

MAINTAIN-pc (Maintaining Activity and Nutrition through Technology-Assisted Innovation in Primary Care) was a randomized trial conducted in coordination with practices affiliated with the University of Pittsburgh Medical Center (UPMC). Participants were recruited between October 2013 and February 2015, and follow-up was completed in March 2017. The University of Pittsburgh Institutional Review Board approved the study, and all participants provided written informed consent.

Participants were randomly assigned to EHR tools (tracking group) versus EHR tools plus coaching (coaching group). The EHR tools included weight, diet, and physical activity tracking flow sheets; standardized surveys; and reminders. Participants in the coaching group received 2 years of personalized health coaching through the EHR patient portal. Three study coaches had backgrounds in nursing, nutrition, and exercise physiology. The other 2 received EHR training, and all received training on the study protocol. Participants were assigned to a specific coach, who contacted the participants via the EHR weekly for 1 month, biweekly in months 2 to 6, monthly in months 7 to 12, and quarterly in months 13 to 24, for a total of 24 scheduled contacts. Coaching group participants received brief questionnaires relevant to weight management, including a text field where they could discuss questions or barriers. On the basis of participant responses and self-monitoring data in the EHR flow sheets, coaches wrote a brief personalized note with advice on questionnaire topics and responses to any queries or barriers mentioned by the participant. Coaching participants who did not complete questionnaires or log information into the flow sheet for 2 weeks were considered inactive and were contacted by telephone or e-mail and invited to reengage at any time. Coaching participants were able to send secure messages to the coach. Tracking group participants received questionnaires related to general health promotion (for example, vaccines) each quarter but received no feedback on questionnaire responses or flow sheet entries.

Referring PCPs of coaching group participants received regular support, including real-time progress reports with counseling tips delivered via the EHR, notification of weight change in increments of at least 10 pounds, and annual progress reports at 12 and 24 months. The progress reports were developed using feedback from PCPs and consisted of a 1-page summary of participant weight (current, trajectory, and goal), status in the program (active or inactive), use of study flow sheets (with data if available), and brief subjective comments from the coach. Reports were delivered to the PCP via the EHR within 48 hours before scheduled office visits. An electronic copy was also sent to the participant. Referring PCPs of tracking group participants received annual progress reports at 12 and 24 months. Information about the development of the intervention and the coaching protocol has been published previously

The trial was initially designed to be a 36-month intervention, with the primary outcome defined as weight change at 36 months. Delays in EHR build and recruitment resulted in a decision after enrollment was completed to shorten the intervention to 24 months, with 24-month weight change as the revised primary outcome. In addition, we added an exploratory 30-month weight outcome to assess the duration of effect after the intervention ended. An updated institutional review board protocol (with revised consent) was approved on 25 September 2015. These changes were made before any data were analyzed.

In the result section, we are reporting all pre-specified outcomes unintentionally omitted in the original ClinicalTrials submission.

Study Design

• Study Type: Interventional
• Actual Enrollment: 194 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Maintaining Activity and Nutrition Through Technology-Assisted Innovation in Primary Care
• Actual Study Start Date: Oct 1, 2013
• Actual Primary Completion Date: Mar 2, 2017
• Actual Study Completion Date: Sep 5, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Coaching Group 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts Online self-monitoring Real-time updates to primary care physicians	Behavioral: 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts.; Participants were assigned to a specific coach, who contacted the participants via the EHR weekly for 1 month, biweekly in months 2 to 6, monthly in months 7 to 12, and quarterly in months 13 to 24, for a total of 24 scheduled contacts. Coaching group participants received brief questionnaires relevant to weight management, including a text field where they could discuss questions or barriers. On the basis of participant responses and self-monitoring data in the EHR flow sheets, coaches wrote a brief personalized note with advice on questionnaire topics and responses to any queries or barriers mentioned by the participant. Coaching participants who did not complete questionnaires or log information into the flow sheet for 2 weeks were considered inactive and were contacted by telephone or e-mail and invited to reengage at any time. Coaching participants were able to send secure messages to the coach.; Behavioral: Online self-monitoring; Participants were encouraged to log in daily and enter data on weight, diet, and physical activity.; Behavioral: Real-time updates to Primary Care physicians; Referring PCPs of coaching group participants received regular support, including real-time progress reports with counseling tips delivered via the EHR, notification of weight change in increments of at least 10 pounds, and annual progress reports at 12 and 24 months.
Active Comparator: Tracking Group -Online self-monitoring	Behavioral: Online self-monitoring; Participants were encouraged to log in daily and enter data on weight, diet, and physical activity.

Outcome Measures

Primary Outcome Measures

1. Body Weight [Baseline to 24 months]

   Weight (kg), change from baseline, Estimate (SE) [95% confidence interval]

Secondary Outcome Measures

1. BMI [Baseline to 24-months]

   Body Mass Index, change from baseline, Estimate (SE) [95% CI]

2. Waist Circumference (cm) [Baseline to 24-months]

   Waist circumference (cm), change from baseline, Estimate (SE) [95% CI]

3. Maintenance of 5% Weight Loss [Baseline to 24-months]

   Participants maintaining 5% weight loss, No (%)

4. Pedometer Steps Per Day [Baseline to 24 months]

   Pedometer steps per day, change from baseline, Estimate (SE) [95% CI]

5. Physical Component Score (SF-36) [Baseline to 24-months]

   Physical Component score, Estimate (SE) [95% CI] The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

6. Mental Component Score (SF-36) [Baseline to 24-months]

   Mental Component score, Estimate (SE) [95% CI] The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

7. WOMAC Function Score [Baseline to 24 months]

   WOMAC function score, change from baseline, Estimate (SE) [95% CI] Western Ontario and McMaster Universities Osteoarthritis Index function scale WOMAC function scores are given on a best-to-worst scale of 0-to-100

8. Systolic Blood Pressure [Baseline to 24-months]

   Systolic Blood Pressure (mmHg), change from baseline, Estimate (SE) [95% CI]

9. Diastolic Blood Pressure [Baseline to 24-months]

   Diastolic Blood Pressure (mmHg), change from baseline, Estimate (SE) [95% CI]

Other Outcome Measures

1. Primary Care Provider (PCP) Satisfaction [12 Months and 30 Months]

   PCP satisfaction and perceived usefulness of a technologic intervention to improve self-management of patients' weight will be assessed at the end of the first year (12 months) and at the end of the study (30 months).

2. Patient Satisfaction [12 Months and 30 Months]

   Patient satisfaction and perceived usefulness of a technologic intervention to improve self-management of weight will be assessed at the end of the first year (12 months) and the end of the study (30 months).

3. Dietary Score [Baseline to 24-months]

   Dietary score, change from baseline, Estimate (SE) [95% CI] Dietary score scale is 0-7. Lower scores indicate a diet that is less heart-healthy.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Eligibility criteria included age 18 to 75 years, body mass index (BMI) of 25 kg/m2 or higher, intentional weight loss of at least 5% in the previous 2 years, access to an Internet-connected computer, and receipt of outpatient care from a UPMC PCP.

Exclusion criteria included a medical explanation for recent weight loss (for example, cancer), active preparation for bariatric surgery, bariatric surgery in the previous 5 years, or pregnancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Research on Health Care	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• University of Pittsburgh
• Agency for Healthcare Research and Quality (AHRQ)

Investigators

• Principal Investigator: Kathleen M McTigue, MD, MPH, MS, University of Pittsburgh

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 23, 2017

More Information

Publications

None provided.

• Responsible Party: Kathleen McTigue, Principal Investigator, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01946191
• Other Study ID Numbers: 1R18HS021162
• First Posted: Sep 19, 2013
• Last Update Posted: Nov 2, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Kathleen McTigue, Principal Investigator, University of Pittsburgh: Weight maintenance; Electronic health record; Primary care
• Additional relevant MeSH terms: Body Weight; Weight Loss

Study Results

Participant Flow

Arm/Group Title	Continued Group	Tracking Group
Arm/Group Description	24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts Online self-monitoring Real-time updates to primary care physicians	Online self-monitoring
Period Title: Allocation
STARTED	98	96
COMPLETED	97	95
NOT COMPLETED	1	1
Period Title: Allocation
STARTED	97	95
COMPLETED	80	77
NOT COMPLETED	17	18
Period Title: Allocation
STARTED	98	95
COMPLETED	80	77
NOT COMPLETED	18	18

Baseline Characteristics

Arm/Group Title	Coaching Group	Tracking Group	Total
Arm/Group Description	Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record	Total of all reporting groups
Overall Participants	98	96	194
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	84 85.7%	75 78.1%	159 82%
>=65 years	14 14.3%	21 21.9%	35 18%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.3 (12)	53.5 (12.4)	53.4 (12.2)
Sex: Female, Male (Count of Participants)
Female	67 68.4%	76 79.2%	143 73.7%
Male	31 31.6%	20 20.8%	51 26.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 1%	2 2.1%	3 1.5%
Not Hispanic or Latino	88 89.8%	83 86.5%	171 88.1%
Unknown or Not Reported	9 9.2%	11 11.5%	20 10.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1%	2 2.1%	3 1.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	8 8.2%	11 11.5%	19 9.8%
White	88 89.8%	83 86.5%	171 88.1%
More than one race	1 1%	0 0%	1 0.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	98 100%	96 100%	194 100%
Non-smoker (Count of Participants)
Count of Participants [Participants]	95 96.9%	94 97.9%	189 97.4%
Education post high school (Count of Participants)
Count of Participants [Participants]	95 96.9%	90 93.8%	185 95.4%
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	88.2 (18.7)	83.3 (19.2)	85.8 (19.1)
Waist circumference (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	99.7 (13.9)	96.2 (16.8)	97.9 (15.5)
Any moderate physical activity (Count of Participants)
Count of Participants [Participants]	93 94.9%	92 95.8%	185 95.4%
Any vigorous physical activity (Count of Participants)
Count of Participants [Participants]	59 60.2%	60 62.5%	119 61.3%
High cholesterol (Count of Participants)
Count of Participants [Participants]	46 46.9%	37 38.5%	83 42.8%
Hypertension (Count of Participants)
Count of Participants [Participants]	56 57.1%	40 41.7%	96 49.5%
Arthritis (Knee and/or Hip) (Count of Participants)
Count of Participants [Participants]	30 30.6%	28 29.2%	58 29.9%
Diabetes or Pre-Diabetes (Count of Participants)
Count of Participants [Participants]	20 20.4%	22 22.9%	42 21.6%
Anxiety/Depression (Count of Participants)
Count of Participants [Participants]	30 30.6%	23 24%	53 27.3%
Systolic blood pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	124.7 (14.2)	121.6 (13.0)	123.2 (13.7)
Diastolic blood pressure (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	75.4 (8.9)	72.7 (10.1)	74.0 (9.6)

Outcome Measures

1. Primary Outcome

Title	Body Weight
Description	Weight (kg), change from baseline, Estimate (SE) [95% confidence interval]
Time Frame	Baseline to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coaching Group	Tracking Group
Arm/Group Description	Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Measure Participants	80	77
Mean (Standard Error) [kg]	2.07 (0.62)	4.93 (0.63)

2. Secondary Outcome

Title	BMI
Description	Body Mass Index, change from baseline, Estimate (SE) [95% CI]
Time Frame	Baseline to 24-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Continued Group	Tracking Group
Arm/Group Description	Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Measure Participants	80	77
Mean (Standard Error) [kg/m^2]	0.80 (0.22)	1.80 (0.23)

3. Secondary Outcome

Title	Waist Circumference (cm)
Description	Waist circumference (cm), change from baseline, Estimate (SE) [95% CI]
Time Frame	Baseline to 24-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coaching Group	Tracking Group
Arm/Group Description	Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Measure Participants	80	77
Mean (Standard Error) [centimeters]	1.34 (0.73)	3.83 (0.74)

4. Secondary Outcome

Title	Maintenance of 5% Weight Loss
Description	Participants maintaining 5% weight loss, No (%)
Time Frame	Baseline to 24-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coaching Group	Tracking Group
Arm/Group Description	Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Measure Participants	80	77
Count of Participants [Participants]	79 80.6%	73 76%

5. Secondary Outcome

Title	Pedometer Steps Per Day
Description	Pedometer steps per day, change from baseline, Estimate (SE) [95% CI]
Time Frame	Baseline to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coaching Group	Tracking Group
Arm/Group Description	Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Measure Participants	80	77
Mean (Standard Error) [Steps per day]	-335.83 (302.24)	-750.68 (302.76)

6. Secondary Outcome

Title	Physical Component Score (SF-36)
Description	Physical Component score, Estimate (SE) [95% CI] The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame	Baseline to 24-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Continued Group	Tracking Group
Arm/Group Description	Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Measure Participants	80	79
Mean (Standard Error) [score on a scale]	-1.95 (0.77)	-3.47 (0.79)

7. Secondary Outcome

Title	Mental Component Score (SF-36)
Description	Mental Component score, Estimate (SE) [95% CI] The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Time Frame	Baseline to 24-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Continued Group	Tracking Group
Arm/Group Description	Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Measure Participants	80	77
Mean (Standard Error) [score]	-2.49 (0.89)	-2.98 (0.09)

8. Secondary Outcome

Title	WOMAC Function Score
Description	WOMAC function score, change from baseline, Estimate (SE) [95% CI] Western Ontario and McMaster Universities Osteoarthritis Index function scale WOMAC function scores are given on a best-to-worst scale of 0-to-100
Time Frame	Baseline to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Continued Group	Tracking Group
Arm/Group Description	Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Measure Participants	80	77
Mean (Standard Error) [score on a scale]	3.20 (1.17)	1.22 (1.19)

9. Secondary Outcome

Title	Systolic Blood Pressure
Description	Systolic Blood Pressure (mmHg), change from baseline, Estimate (SE) [95% CI]
Time Frame	Baseline to 24-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Continued Group	Tracking Group
Arm/Group Description	Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Measure Participants	80	77
Mean (Standard Error) [mmHg]	4.63 (1.49)	8.44 (1.53)

10. Secondary Outcome

Title	Diastolic Blood Pressure
Description	Diastolic Blood Pressure (mmHg), change from baseline, Estimate (SE) [95% CI]
Time Frame	Baseline to 24-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Continued Group	Tracking Group
Arm/Group Description	Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Measure Participants	80	77
Mean (Standard Error) [mmHg]	2.78 (0.95)	4.58 (0.98)

11. Other Pre-specified Outcome

Title	Primary Care Provider (PCP) Satisfaction
Description	PCP satisfaction and perceived usefulness of a technologic intervention to improve self-management of patients' weight will be assessed at the end of the first year (12 months) and at the end of the study (30 months).
Time Frame	12 Months and 30 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

12. Other Pre-specified Outcome

Title	Patient Satisfaction
Description	Patient satisfaction and perceived usefulness of a technologic intervention to improve self-management of weight will be assessed at the end of the first year (12 months) and the end of the study (30 months).
Time Frame	12 Months and 30 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

13. Other Pre-specified Outcome

Title	Dietary Score
Description	Dietary score, change from baseline, Estimate (SE) [95% CI] Dietary score scale is 0-7. Lower scores indicate a diet that is less heart-healthy.
Time Frame	Baseline to 24-months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Continued Group	Tracking Group
Arm/Group Description	Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment	Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
Measure Participants	80	77
Mean (Standard Error) [score on a scale]	-0.21 (0.14)	-0.23 (0.15)

Adverse Events

Time Frame	24-months
Adverse Event Reporting Description	For adverse medical events, the following guidelines were used to describe severity. Mild Moderate Severe Participants were asked about any adverse medical events that might have affected their participation in usual daily activities at each follow-up assessment and self-rated the severity of the event (as opposed to a formal adjudication process).
Arm/Group Title	Continued Group		Tracking Group
Arm/Group Description	Online self-monitoring along with health coach electronic communication and support and real-time updates to primary care physicians Health coach electronic communication and support: Health coach reviews responses to weight-related surveys and provides feedback and advice Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record Real-time updates to Primary Care physicians: Primary care physicians will receive updates through electronic health record system before each scheduled appointment		Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record
All Cause Mortality
	Continued Group		Tracking Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0%)		0/96 (0%)
Serious Adverse Events
	Continued Group		Tracking Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/98 (0%)		0/96 (0%)
Other (Not Including Serious) Adverse Events
	Continued Group		Tracking Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	48/98 (49%)		67/96 (69.8%)
General disorders
Severe events	10/98 (10.2%)	10	20/96 (20.8%)	20
Moderate	28/98 (28.6%)	28	33/96 (34.4%)	33
Mild	10/98 (10.2%)	10	14/96 (14.6%)	14

Limitations/Caveats

1)Single-site trial and study population (26%men and 12%non-white) limits generalizability 2)Staff not blinded, leads to some bias in assessment 4)Missing data introduces potential bias in outcomes 5) 24-month endpoint lead to a shorter intervention

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.