Body Weight, Motor Activity, Weight Loss
Conditions
Keywords
Weight maintenance, Electronic health record, Primary care
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.
Interventions
BEHAVIORAL24 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.
BEHAVIORALOnline self-monitoring
Participants were encouraged to log in daily and enter data on weight, diet, and physical activity.
BEHAVIORALReal-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.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | Baseline to 24 months | Weight (kg), change from baseline, Estimate (SE) \[95% confidence interval\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pedometer Steps Per Day | Baseline to 24 months | Pedometer steps per day, change from baseline, Estimate (SE) \[95% CI\] |
| WOMAC Function Score | Baseline to 24 months | 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 |
| Systolic Blood Pressure | Baseline to 24-months | Systolic Blood Pressure (mmHg), change from baseline, Estimate (SE) \[95% CI\] |
| Diastolic Blood Pressure | Baseline to 24-months | Diastolic Blood Pressure (mmHg), change from baseline, Estimate (SE) \[95% CI\] |
| BMI | Baseline to 24-months | Body Mass Index, change from baseline, Estimate (SE) \[95% CI\] |
| Waist Circumference (cm) | Baseline to 24-months | Waist circumference (cm), change from baseline, Estimate (SE) \[95% CI\] |
| Maintenance of 5% Weight Loss | Baseline to 24-months | Participants maintaining 5% weight loss, No (%) |
| Physical Component Score (SF-36) | Baseline to 24-months | 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. |
| Mental Component Score (SF-36) | Baseline to 24-months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Dietary Score | Baseline to 24-months | 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. |
| Patient Satisfaction | 12 Months and 30 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). |
| Primary Care Provider (PCP) Satisfaction | 12 Months and 30 Months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 98 |
| Tracking Group Online self-monitoring
Online self-monitoring: Tracking weight, calories, fat grams, and physical activity in electronic personal health record | 96 |
| Total | 194 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Allocation | Did not complete orientation | 1 | 1 |
| Follow-Up, 24-mo Endpoint | Lost to Follow-up | 13 | 15 |
| Follow-Up, 24-mo Endpoint | Protocol Violation | 0 | 1 |
| Follow-Up, 24-mo Endpoint | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Coaching Group | Tracking Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 21 Participants | 35 Participants |
| Age, Categorical Between 18 and 65 years | 84 Participants | 75 Participants | 159 Participants |
| Age, Continuous | 53.3 years STANDARD_DEVIATION 12 | 53.5 years STANDARD_DEVIATION 12.4 | 53.4 years STANDARD_DEVIATION 12.2 |
| Anxiety/Depression | 30 Participants | 23 Participants | 53 Participants |
| Any moderate physical activity | 93 Participants | 92 Participants | 185 Participants |
| Any vigorous physical activity | 59 Participants | 60 Participants | 119 Participants |
| Arthritis (Knee and/or Hip) | 30 Participants | 28 Participants | 58 Participants |
| Diabetes or Pre-Diabetes | 20 Participants | 22 Participants | 42 Participants |
| Diastolic blood pressure | 75.4 mm Hg STANDARD_DEVIATION 8.9 | 72.7 mm Hg STANDARD_DEVIATION 10.1 | 74.0 mm Hg STANDARD_DEVIATION 9.6 |
| Education post high school | 95 Participants | 90 Participants | 185 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants | 83 Participants | 171 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 9 Participants | 11 Participants | 20 Participants |
| High cholesterol | 46 Participants | 37 Participants | 83 Participants |
| Hypertension | 56 Participants | 40 Participants | 96 Participants |
| Non-smoker | 95 Participants | 94 Participants | 189 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 11 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 88 Participants | 83 Participants | 171 Participants |
| Region of Enrollment United States | 98 Participants | 96 Participants | 194 Participants |
| Sex: Female, Male Female | 67 Participants | 76 Participants | 143 Participants |
| Sex: Female, Male Male | 31 Participants | 20 Participants | 51 Participants |
| Systolic blood pressure | 124.7 mm Hg STANDARD_DEVIATION 14.2 | 121.6 mm Hg STANDARD_DEVIATION 13 | 123.2 mm Hg STANDARD_DEVIATION 13.7 |
| Waist circumference | 99.7 cm STANDARD_DEVIATION 13.9 | 96.2 cm STANDARD_DEVIATION 16.8 | 97.9 cm STANDARD_DEVIATION 15.5 |
| Weight | 88.2 kg STANDARD_DEVIATION 18.7 | 83.3 kg STANDARD_DEVIATION 19.2 | 85.8 kg STANDARD_DEVIATION 19.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 96 |
| other Total, other adverse events | 48 / 98 | 67 / 96 |
| serious Total, serious adverse events | 0 / 98 | 0 / 96 |
Outcome results
Primary
Body Weight
Weight (kg), change from baseline, Estimate (SE) \[95% confidence interval\]
Time frame: Baseline to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching Group | Body Weight | 2.07 kg | Standard Error 0.62 |
| Tracking Group | Body Weight | 4.93 kg | Standard Error 0.63 |
Secondary
BMI
Body Mass Index, change from baseline, Estimate (SE) \[95% CI\]
Time frame: Baseline to 24-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching Group | BMI | 0.80 kg/m^2 | Standard Error 0.22 |
| Tracking Group | BMI | 1.80 kg/m^2 | Standard Error 0.23 |
Secondary
Diastolic Blood Pressure
Diastolic Blood Pressure (mmHg), change from baseline, Estimate (SE) \[95% CI\]
Time frame: Baseline to 24-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching Group | Diastolic Blood Pressure | 2.78 mmHg | Standard Error 0.95 |
| Tracking Group | Diastolic Blood Pressure | 4.58 mmHg | Standard Error 0.98 |
Secondary
Maintenance of 5% Weight Loss
Participants maintaining 5% weight loss, No (%)
Time frame: Baseline to 24-months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coaching Group | Maintenance of 5% Weight Loss | 79 Participants |
| Tracking Group | Maintenance of 5% Weight Loss | 73 Participants |
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.
Time frame: Baseline to 24-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching Group | Mental Component Score (SF-36) | -2.49 score | Standard Error 0.89 |
| Tracking Group | Mental Component Score (SF-36) | -2.98 score | Standard Error 0.09 |
Secondary
Pedometer Steps Per Day
Pedometer steps per day, change from baseline, Estimate (SE) \[95% CI\]
Time frame: Baseline to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching Group | Pedometer Steps Per Day | -335.83 Steps per day | Standard Error 302.24 |
| Tracking Group | Pedometer Steps Per Day | -750.68 Steps per day | Standard Error 302.76 |
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.
Time frame: Baseline to 24-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching Group | Physical Component Score (SF-36) | -1.95 score on a scale | Standard Error 0.77 |
| Tracking Group | Physical Component Score (SF-36) | -3.47 score on a scale | Standard Error 0.79 |
Secondary
Systolic Blood Pressure
Systolic Blood Pressure (mmHg), change from baseline, Estimate (SE) \[95% CI\]
Time frame: Baseline to 24-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching Group | Systolic Blood Pressure | 4.63 mmHg | Standard Error 1.49 |
| Tracking Group | Systolic Blood Pressure | 8.44 mmHg | Standard Error 1.53 |
Secondary
Waist Circumference (cm)
Waist circumference (cm), change from baseline, Estimate (SE) \[95% CI\]
Time frame: Baseline to 24-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching Group | Waist Circumference (cm) | 1.34 centimeters | Standard Error 0.73 |
| Tracking Group | Waist Circumference (cm) | 3.83 centimeters | Standard Error 0.74 |
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
Time frame: Baseline to 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching Group | WOMAC Function Score | 3.20 score on a scale | Standard Error 1.17 |
| Tracking Group | WOMAC Function Score | 1.22 score on a scale | Standard Error 1.19 |
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.
Time frame: Baseline to 24-months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Coaching Group | Dietary Score | -0.21 score on a scale | Standard Error 0.14 |
| Tracking Group | Dietary Score | -0.23 score on a scale | Standard Error 0.15 |
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).
Time frame: 12 Months and 30 Months
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).
Time frame: 12 Months and 30 Months