Body WeightMAINTAIN-PCNCT01946191
Computer-Based Weight Maintenance in Primary Care
A study testing 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts., Online self-monitoring and Real-time updates to Primary Care physicians in people with Body Weight and Weight Loss, run by University of Pittsburgh at 1 site in United States.
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%. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Body Weight, Weight Loss, Motor Activity
- What is being tested?
- 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts., Online self-monitoring and Real-time updates to Primary Care physicians
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2013to 5 Sep 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Research on Health Care
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Maintaining Activity and Nutrition Through Technology-Assisted Innovation in Primary Care
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%.
Read the 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.
- Conditions
- Body Weight, Weight Loss, Motor Activity
- Being tested
- 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts., Online self-monitoring, Real-time updates to Primary Care physicians
- Keywords
- Weight maintenance, Electronic health record, Primary care
- Medical subject headings
- Body Weight, Weight Loss, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts.Behavioural
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-monitoringBehavioural
Participants were encouraged to log in daily and enter data on weight, diet, and physical activity.
Real-time updates to Primary Care physiciansBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Coaching Group | Experimental | * 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts
* Online self-monitoring
* Real-time updates to primary care physicians Receives: 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 |
| Tracking Group | Active comparator | -Online self-monitoring Receives: Behavioral: Online self-monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Weight (kg), change from baseline, Estimate (SE) [95% confidence interval]
Measured: Baseline to 24 months
Secondary outcomes (9)
BMI
Body Mass Index, change from baseline, Estimate (SE) [95% CI]
Measured: Baseline to 24-months
Waist Circumference (cm)
Waist circumference (cm), change from baseline, Estimate (SE) [95% CI]
Measured: Baseline to 24-months
Maintenance of 5% Weight Loss
Participants maintaining 5% weight loss, No (%)
Measured: Baseline to 24-months
Pedometer Steps Per Day
Pedometer steps per day, change from baseline, Estimate (SE) [95% CI]
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline to 24 months
Systolic Blood Pressure
Systolic Blood Pressure (mmHg), change from baseline, Estimate (SE) [95% CI]
Measured: Baseline to 24-months
Diastolic Blood Pressure
Diastolic Blood Pressure (mmHg), change from baseline, Estimate (SE) [95% CI]
Measured: Baseline to 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study start1 Oct 2013
- Primary completion2 Mar 2017
- Study completion5 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Body WeightStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Kathleen McTigue, University of Pittsburgh
- Investigators
- Kathleen M McTigue, MD, MPH, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946191
- Sponsor's protocol ID
- 1R18HS021162
- Acronym
- MAINTAIN-PC
- Status last verified
- Oct 2020
- First submitted
- 16 Sep 2013
- Last updated
- 2 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data from this study may be requested by researchers after the completion of the primary endpoint publication by contacting Dr. Conroy.
Publications
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.
PubMed 28089764Gibbs 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.
PubMed 29130068Conroy 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.
PubMed 31711168Gibbs 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.
PubMed 32808209
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Activity and Nutrition Through Technology-Assisted Innovation in Primary Care
- ClinicalTrials.gov ID
- NCT01946191
- Acronym / sponsor ID
- MAINTAIN-PC / 1R18HS021162
- Conditions
- Body Weight, Weight Loss, Motor Activity
- Keywords
- Weight maintenance, Electronic health record, Primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Posted 2 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coaching Group | Experimental | 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* 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts * Online self-monitoring * Real-time updates to primary care physicians |
| Tracking Group | Active comparator | Behavioral: Online self-monitoring-Online self-monitoring |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Coaching Group |
| Online self-monitoringParticipants were encouraged to log in daily and enter data on weight, diet, and physical activity. | Behavioural | Coaching Group, Tracking Group |
| Real-time updates to Primary Care physiciansReferring 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. | Behavioural | Coaching Group |
Primary outcome
Body Weight
Time frame: Baseline to 24 months
Weight (kg), change from baseline, Estimate (SE) [95% confidence interval]
9 secondary outcomes
BMI
Time frame: Baseline to 24-months
Waist Circumference (cm)
Time frame: Baseline to 24-months
Maintenance of 5% Weight Loss
Time frame: Baseline to 24-months
Pedometer Steps Per Day
Time frame: Baseline to 24 months
Physical Component Score (SF-36)
Time frame: Baseline to 24-months
Mental Component Score (SF-36)
Time frame: Baseline to 24-months
WOMAC Function Score
Time frame: Baseline to 24 months
Systolic Blood Pressure
Time frame: Baseline to 24-months
Diastolic Blood Pressure
Time frame: Baseline to 24-months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28089764Conroy 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.
- Results publication: PubMed 29130068Gibbs 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.
- Results publication: PubMed 31711168Conroy 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.
- Derived from this study: PubMed 32808209Gibbs 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.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen M McTigue, MD, MPH, MS principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts., Online self-monitoring and Real-time updates to Primary Care physicians in people with Body Weight and Weight Loss, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Weight (time frame: Baseline to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01946191, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2020.