N/A
N=840
Integrating Online Weight Management With Primary Care Support
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02656693 ↗Enrolled (actual)
840
Serious AEs
4.9%
Results posted
Aug 2019
Primary outcome: Primary: Change in Body Weight at 12 Months — -1.2; -1.9; -3.1 kilograms — p=0.00017
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Online weight management program (Behavioral); Population health management support (Behavioral)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Body Weight at 12 Months |
-1.2; -1.9; -3.1 | 0.00017 sig |
| SECONDARY Change in Body Weight at 6 Months |
-1.0; -2.1; -2.9 | — |
| SECONDARY Change in Body Weight at 18 Months |
-1.9; -1.1; -2.8 | < 0.001 sig |
| SECONDARY Percent Weight Change at 6 Months |
-1.0; -2.0; -2.8 | — |
| SECONDARY Percent Weight Change at 12-Months |
-1.4; -1.9; -3.0 | < 0.001 sig |
| SECONDARY Percent Weight Change at 18-Months |
-1.9; -0.9; -2.6 | 0.01 sig |
| SECONDARY Percent of Patients With at Least 5% Weight Loss at 6 Months |
13.4; 22.1; 29.5 | — |
| SECONDARY Percent of Patients With at Least 5% Weight Loss at 12-months |
14.9; 20.8; 32.3 | <0.001 sig |
| SECONDARY Percent of Patients With at Least 5% Weight Loss at 18 Months |
20.9; 19.9; 31.3 | 0.20 |
| SECONDARY Changes in Self-efficacy Around Weight Loss at 12 Months |
-0.7; -0.4; 0.5 | 0.0001 sig |
| SECONDARY Changes in Systolic Blood Pressure |
-0.9; -3.0; -0.2 | 0.19 |
| SECONDARY Changes in Diastolic Blood Pressure |
-1.0; -2.2; -1.1 | 0.35 |
| SECONDARY Changes in Total Cholesterol |
-7.5; -6.3; -6.8 | 0.20 |
| SECONDARY Changes in HDL Cholesterol |
-0.4; 0.6; 0.7 | 0.33 |
| SECONDARY Changes in LDL Cholesterol |
-5.4; -3.7; -5.8 | 0.43 |
| SECONDARY Changes in Triglycerides |
-12.4; -8.0; -10.2 | 0.40 |
| SECONDARY Changes in HbA1c Levels |
-0.02; 0.02; -0.02 | 0.16 |
| SECONDARY Changes in Weight-related Quality of Life Assessed by the Impact of Weight on Quality of Life (IWQOL)-Lite Questionnaire |
5.4; 4.8; 5.8 | 0.61 |
| SECONDARY Changes in Percentage of Patients Reporting Excellent/Very Good Health Status Assessed by Using a 5-point Scale Questionnaire From the 36-Item Short Form Health Survey(SF-36) |
14.5; 16.1; 21.4 | 0.61 |
| SECONDARY Changes in Self-reported Physical Activity |
5.7; 2.6; 3.5 | 0.46 |
| SECONDARY Changes in Diet, Specifically Fruits/Vegetables, as Measured by the PrimeScreen Questionnaire |
0.4; 0.3; 0.4 | 0.68 |
| SECONDARY Changes in Diet, Specifically Whole Grains, as Measured by the PrimeScreen Questionnaire |
0.02; 0.03; 0.1 | 0.54 |
| SECONDARY Changes in Diet, Specifically Sugar-sweetened Beverages, as Measured by the PrimeScreen Questionnaire |
0.01; -0.1; -0.1 | 0.09 |
| SECONDARY Changes in Diet, Specifically Baked Products, as Measured by the PrimeScreen Questionnaire |
-0.1; -0.1; -0.1 | 0.42 |
| SECONDARY Changes in Diet, Specifically Processed Meats, as Measured by the PrimeScreen Questionnaire |
-0.02; -0.1; -0.1 | 0.23 |
| SECONDARY Changes in Diet, Specifically Fried Foods, as Measured by the PrimeScreen Questionnaire |
-0.03; -0.02; -0.1 | 0.20 |
Summary
The goal of this project is to adapt an evidence-based online weight management program and integrate it with population management support from primary care practices. Investigators then will conduct a three-arm, cluster-randomized trial to compare the effectiveness of 1) the combined intervention (online weight management program plus population management support) with 2) the stand-alone online weight management program and with 3) usual care, among overweight and obese primary care patients with type 2 diabetes or hypertension. The specific aims are:
1. a. To adapt an online weight management program and integrate it with population management support, incorporating input from patients, primary care clinicians, and other stakeholders; afterward, investigators will acquire feedback on the positive and negative aspects of the intervention.
b. To compare the effectiveness of the combined intervention (online weight management program plus population management support) with the stand-alone online program and with usual care.
Hypothesis 1: The combined intervention will lead to greater weight loss at 12 months compared with the stand-alone online program and with usual care.
2. To identify mediators of the combined intervention and the stand-alone online program.
Hypothesis 2: The effects of the combined intervention and the stand-alone online program on weight loss will be mediated by patients' level of engagement, changes in self-efficacy, and changes in diet and physical activity.
3. To explore whether the effectiveness of the combined intervention and the stand-alone weight management program varies by patient characteristics.
Hypothesis 3: The interventions will be more effective among patients who are younger, white, and higher socioeconomic status, although the population management strategy may help to reduce these differences.
Eligibility Criteria
Inclusion Criteria
- upcoming or recent visit at primary care practice affiliated with Brigham and Women's Hospital
- age 20-70
- diagnosis of type 2 diabetes and/or hypertension
- BMI >= 27 and 5% weight loss in the last 6 months 7. Severe psychiatric illness or impaired mental status 8. Active or diagnosed history of and/or self-reported history of eating disorders 9. Self-reported average consumption of > 14 alcoholic drinks/week 10. Any serious medical condition that would affect weight loss or for which weight loss is contraindicated, including active cancer (excluding non-melanoma skin cancer) or currently being treated for cancer, end stage renal disease (ESRD) on dialysis, etc.
- On comfort care measures, hospice, or in nursing home 12. Participating in a contra-indicative research study 13. Use of prescription or over-the-counter weight loss medications or an all-liquid diet program in the last 6 months or currently 14. Any other medical contraindication for weight loss or physical activity, or any other reason that the PCP or their delegate (e.g., LPN or RN) did not deem the patient appropriate for the study
Data sourced from ClinicalTrials.gov (NCT02656693). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.