Computer-Based Weight Maintenance in Primary Care

Weight Loss Clinical Trial

— MAINTAIN-PC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946191
• Other study ID #: 1R18HS021162
• Status: Completed
• Phase: N/A
• Start date: October 1, 2013
• Est. completion date: September 5, 2017

Study information

• Verified date: October 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: September 5, 2017
• Est. primary completion date: March 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Motor Activity
• Weight Loss

Intervention

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.
• Online self-monitoring
Participants were encouraged to log in daily and enter data on weight, diet, and physical activity.
• 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.

Locations

Country	Name	City	State
United States	Center for Research on Health Care	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Conroy MB, Bryce CL, McTigue KM, Tudorascu D, Gibbs BB, Comer D, Hess R, Huber K, Simkin-Silverman LR, Fischer GS. Promoting weight maintenance with electronic health record tools in a primary care setting: Baseline results from the MAINTAIN-pc trial. Con — View Citation

Conroy MB, McTigue KM, Bryce CL, Tudorascu D, Gibbs BB, Arnold J, Comer D, Hess R, Huber K, Simkin-Silverman LR, Fischer GS. Effect of Electronic Health Record-Based Coaching on Weight Maintenance: A Randomized Trial. Ann Intern Med. 2019 Dec 3;171(11):77 — View Citation

Gibbs BB, Tudorascu D, Bryce CL, Comer D, Fischer GS, Hess R, Huber KA, McTigue KM, Simkin-Silverman LR, Conroy MB. Diet and Physical Activity Behaviors in Primary Care Patients with Recent Intentional Weight Loss. Transl J Am Coll Sports Med. 2017;2(18): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Primary Care Provider (PCP) Satisfaction	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).	12 Months and 30 Months
Other	Patient Satisfaction	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).	12 Months and 30 Months
Other	Dietary Score	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.	Baseline to 24-months
Primary	Body Weight	Weight (kg), change from baseline, Estimate (SE) [95% confidence interval]	Baseline to 24 months
Secondary	BMI	Body Mass Index, change from baseline, Estimate (SE) [95% CI]	Baseline to 24-months
Secondary	Waist Circumference (cm)	Waist circumference (cm), change from baseline, Estimate (SE) [95% CI]	Baseline to 24-months
Secondary	Maintenance of 5% Weight Loss	Participants maintaining 5% weight loss, No (%)	Baseline to 24-months
Secondary	Pedometer Steps Per Day	Pedometer steps per day, change from baseline, Estimate (SE) [95% CI]	Baseline to 24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Systolic Blood Pressure	Systolic Blood Pressure (mmHg), change from baseline, Estimate (SE) [95% CI]	Baseline to 24-months
Secondary	Diastolic Blood Pressure	Diastolic Blood Pressure (mmHg), change from baseline, Estimate (SE) [95% CI]	Baseline to 24-months