Computer-Based Weight Maintenance in Primary Care

Study Overview
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Brief Summary
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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%.

Detailed Description
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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.

Official Title
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Maintaining Activity and Nutrition Through Technology-Assisted Innovation in Primary Care

Conditions
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Motor Activity, Body Weight, Weight Loss

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coaching Group<br>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.<br>* 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.<br>Behavioral: Online self-monitoring<br>* Participants were encouraged to log in daily and enter data on weight, diet, and physical activity.<br>Behavioral: Real-time updates to Primary Care physicians<br>* 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.<br>|
| Active Comparator: Tracking Group<br>-Online self-monitoring | Behavioral: Online self-monitoring<br>* Participants were encouraged to log in daily and enter data on weight, diet, and physical activity.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI | Body Mass Index, change from baseline, Estimate (SE) [95% CI] | Baseline to 24-months | 
| Waist Circumference (cm) | Waist circumference (cm), change from baseline, Estimate (SE) [95% CI] | Baseline to 24-months | 
| Maintenance of 5% Weight Loss | Participants maintaining 5% weight loss, No (%) | Baseline to 24-months | 
| Pedometer Steps Per Day | Pedometer steps per day, change from baseline, Estimate (SE) [95% CI] | Baseline to 24 months | 
| Physical Component Score (SF-36) | 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. | Baseline to 24-months | 
| Mental Component Score (SF-36) | 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. | Baseline to 24-months | 
| WOMAC Function Score | 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 | Baseline to 24 months | 
| Systolic Blood Pressure | Systolic Blood Pressure (mmHg), change from baseline, Estimate (SE) [95% CI] | Baseline to 24-months | 
| Diastolic Blood Pressure | Diastolic Blood Pressure (mmHg), change from baseline, Estimate (SE) [95% CI] | Baseline to 24-months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight maintenance, Electronic health record, Primary care