Ignite Creation Date:
2024-05-06 @ 1:59 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01946191
Status:
COMPLETED
Last Update Posted:
2020-11-02
First Post:
2013-09-16
Brief Title:
Computer-Based Weight Maintenance in Primary Care
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Maintaining Activity and Nutrition Through Technology-Assisted Innovation in Primary Care
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAINTAIN-PC
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None