Computer-Based Weight Maintenance in Primary Care
Condition: Body Weight; Weight Loss; Motor Activity
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

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%.
    

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.
    

Intervention name(s): 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts.; Online self-monitoring; Real-time updates to Primary Care physicians
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 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.; Participants were encouraged to log in daily and enter data on weight, diet, and physical activity.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Weight maintenance; Electronic health record; Primary care