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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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%.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coaching Group | Experimental |
|
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| Tracking Group | Active Comparator | -Online self-monitoring |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts. | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Weight (kg), change from baseline, Estimate (SE) [95% confidence interval] | Baseline to 24 months |
| 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] |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient Satisfaction |
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.
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M McTigue, MD, MPH, MS | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Research on Health Care | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28089764 | Result | 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. Contemp Clin Trials. 2017 Mar;54:60-67. doi: 10.1016/j.cct.2017.01.001. Epub 2017 Jan 12. | |
| 29130068 | Result | 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):114-121. Epub 2017 Sep 15. |
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Data from this study may be requested by researchers after the completion of the primary endpoint publication by contacting Dr. Conroy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Continued Group |
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| FG001 | Tracking Group | Online self-monitoring |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allocation |
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| Follow-Up, 24-mo Endpoint |
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| Primary Outcome Analysis |
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| ID | Title | Description |
|---|---|---|
| BG000 | Coaching Group | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Body Weight | Weight (kg), change from baseline, Estimate (SE) [95% confidence interval] | Posted | Mean | Standard Error | kg | Baseline to 24 months |
|
24-months
For adverse medical events, the following guidelines were used to describe severity.
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Continued Group | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe events | General disorders | Systematic Assessment | •Severe - interrupt a participant's usual daily activity. Severe events are usually potentially life-threatening or incapacitating. Of note, the term "severe" does not necessarily equate to "serious" |
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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Molly Conroy | University of Utah | 801-581-8310 | Molly.Conroy@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2017 | Nov 12, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001835 | Body Weight |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001519 | Behavior |
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| Online self-monitoring | Behavioral | Participants were encouraged to log in daily and enter data on weight, diet, and physical activity. |
|
| Real-time updates to Primary Care physicians | Behavioral | 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. |
|
| 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 |
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 |
| 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 |
| 31711168 | Result | 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):777-784. doi: 10.7326/M18-3337. Epub 2019 Nov 12. |
| 32808209 | Derived | Gibbs BB, Tudorascu D, Bryce CL, Comer D, Fischer GS, Hess R, Huber KA, McTigue KM, Simkin-Silverman LR, Conroy MB. Lifestyle Habits Associated with Weight Regain After Intentional Loss in Primary Care Patients Participating in a Randomized Trial. J Gen Intern Med. 2020 Nov;35(11):3227-3233. doi: 10.1007/s11606-020-06056-x. Epub 2020 Aug 17. |
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| BG001 | Tracking Group | Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Non-smoker | Count of Participants | Participants |
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| Education post high school | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Waist circumference | Mean | Standard Deviation | cm |
|
| Any moderate physical activity | Moderate and vigorous physical activity are the n (%) of participants reporting any of each type of PA on the baseline BRFSS physical activity survey | Count of Participants | Participants |
|
| Any vigorous physical activity | Moderate and vigorous physical activity are the n (%) of participants reporting any of each type of PA on the baseline BRFSS physical activity survey | Count of Participants | Participants |
|
| High cholesterol | Count of Participants | Participants |
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| Hypertension | Count of Participants | Participants |
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| Arthritis (Knee and/or Hip) | Count of Participants | Participants |
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| Diabetes or Pre-Diabetes | Count of Participants | Participants |
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| Anxiety/Depression | Count of Participants | Participants |
|
| Systolic blood pressure | Mean | Standard Deviation | mm Hg |
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| Diastolic blood pressure | Mean | Standard Deviation | mm Hg |
|
Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record |
|
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| Secondary | BMI | Body Mass Index, change from baseline, Estimate (SE) [95% CI] | Posted | Mean | Standard Error | kg/m^2 | Baseline to 24-months |
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| Secondary | Waist Circumference (cm) | Waist circumference (cm), change from baseline, Estimate (SE) [95% CI] | Posted | Mean | Standard Error | centimeters | Baseline to 24-months |
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| Secondary | Maintenance of 5% Weight Loss | Participants maintaining 5% weight loss, No (%) | Posted | Count of Participants | Participants | Baseline to 24-months |
|
|
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| Secondary | Pedometer Steps Per Day | Pedometer steps per day, change from baseline, Estimate (SE) [95% CI] | Posted | Mean | Standard Error | Steps per day | Baseline to 24 months |
|
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| 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. | Posted | Mean | Standard Error | score on a scale | Baseline to 24-months |
|
|
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| 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. | Posted | Mean | Standard Error | score | Baseline to 24-months |
|
|
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| 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 | Posted | Mean | Standard Error | score on a scale | Baseline to 24 months |
|
|
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| Secondary | Systolic Blood Pressure | Systolic Blood Pressure (mmHg), change from baseline, Estimate (SE) [95% CI] | Posted | Mean | Standard Error | mmHg | Baseline to 24-months |
|
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| Secondary | Diastolic Blood Pressure | Diastolic Blood Pressure (mmHg), change from baseline, Estimate (SE) [95% CI] | Posted | Mean | Standard Error | mmHg | Baseline to 24-months |
|
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| Other Pre-specified | 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). | Not Posted | 12 Months and 30 Months | Participants |
| Other Pre-specified | 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). | Not Posted | 12 Months and 30 Months | Participants |
| Other Pre-specified | 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. | Posted | Mean | Standard Error | score on a scale | Baseline to 24-months |
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| 0 |
| 98 |
| 0 |
| 98 |
| 48 |
| 98 |
| EG001 | Tracking Group | Online self-monitoring Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record | 0 | 96 | 0 | 96 | 67 | 96 |
|
| Moderate | General disorders | Systematic Assessment | Moderate - Events result in a low level of inconvenience or concern with the intervention measures. Moderate events may cause some interference with functioning |
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| Mild | General disorders | Systematic Assessment | •Mild - Events require minimal or no treatment and do not interfere with the participant's daily activities |
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