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This purpose of this trial is to determine whether a 12-month eHealth behavioral intervention that includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls, and primary care physician (PCP) counseling will produce greater weight change at 12 months than a standard primary care control.
This is a patient randomized trial in which patients will be randomized into one of two treatment arms: 1) standard primary care; or 2) primary care plus a 12-month eHealth behavioral intervention (iOTA), which includes interactive self-monitoring and feedback, tailored skills training materials, 18 telephone counseling calls, and primary care provider counseling. The primary outcome is weight change at 12 months. Participants will be 351 adult male and female patients from local community health centers with obesity and a related comorbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eHealth weight loss intervention | Experimental | The 12-month eHealth behavioral intervention includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls from a study coach, and primary care provider counseling. |
|
| Usual care | No Intervention | Participants in the usual care arm will receive the usual primary care services offered by their community health center primary care providers. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eHealth weight loss intervention | Behavioral | This trial involves a multi-level, systems-change weight loss intervention. At the provider level, we make it easier for PCPs to deliver weight loss counseling by embedding patient progress data and counseling recommendations in the electronic health record. At the patient level, we provide engaging self-monitoring interfaces, immediate tailored feedback, skills training, and evidence-based lifestyle counseling from trusted care providers. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change | Weight will be measured at baseline and 12 months using a SECA 876 scale. | Baseline - 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The achievement and maintenance of > 5% weight loss | Weight will be measured at baseline and 12 months using a SECA 876 scale. | Baseline - 12 months |
| Diet | Dietary assessments will be performed at baseline and 12 months using the ASA24, a self-administered dietary recall measure developed by the National Cancer Institute. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Bennett, PhD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32985131 | Derived | Gallis JA, Kusibab K, Egger JR, Olsen MK, Askew S, Steinberg DM, Bennett G. Can Electronic Health Records Validly Estimate the Effects of Health System Interventions Aimed at Controlling Body Weight? Obesity (Silver Spring). 2020 Nov;28(11):2107-2115. doi: 10.1002/oby.22958. Epub 2020 Sep 27. | |
| 30905430 | Derived |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Baseline - 12 months |
| Cardiometabolic risk markers | Risk markers include waist circumference, systolic and diastolic blood pressure, lipid panel and A1c levels | Baseline - 12 months |
| Global Framingham risk score | The Framingham Risk Score is a validated scoring system used to determine an individual's chances of developing cardiovascular disease. We will calculate this score at baseline and 12 months. | Baseline - 12 months |
| An evaluation of the intervention's impact and dissemination potential using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework | RE-AIM was originally developed as a framework for consistent reporting of research results and later used to organize reviews of the existing literature on health promotion and disease management in different settings. The acronym stands for Reach, Effectiveness, Adoption, Implementation, and Maintenance which together determine public health impact. More recently, RE-AIM has been used to translate research into practice and to help plan programs and improve their chances of working in "real-world" settings. The framework has also been used to understand the relative strengths and weaknesses of different approaches to health promotion and chronic disease self-management-such as in-person counseling, group education classes, telephone counseling, and internet resources. | 12 and 24 months |
| Physical activity | Physical activity will be measured at baseline and 12 months using the GPAQ (the Global Physical Activity Questionnaire developed by the World Health Organization). | Baseline -12 months |
| Steinberg D, Kay M, Burroughs J, Svetkey LP, Bennett GG. The Effect of a Digital Behavioral Weight Loss Intervention on Adherence to the Dietary Approaches to Stop Hypertension (DASH) Dietary Pattern in Medically Vulnerable Primary Care Patients: Results from a Randomized Controlled Trial. J Acad Nutr Diet. 2019 Apr;119(4):574-584. doi: 10.1016/j.jand.2018.12.011. |
| 30891688 | Derived | McVay M, Steinberg D, Askew S, Bennett GG. Provider Counseling and Weight Loss Outcomes in a Primary Care-Based Digital Obesity Treatment. J Gen Intern Med. 2019 Jun;34(6):992-998. doi: 10.1007/s11606-019-04944-5. Epub 2019 Mar 19. |
| 30361140 | Derived | Bennett GG, Steinberg D, Askew S, Levine E, Foley P, Batch BC, Svetkey LP, Bosworth HB, Puleo EM, Brewer A, DeVries A, Miranda H. Effectiveness of an App and Provider Counseling for Obesity Treatment in Primary Care. Am J Prev Med. 2018 Dec;55(6):777-786. doi: 10.1016/j.amepre.2018.07.005. Epub 2018 Oct 22. |
| 26995281 | Derived | Foley P, Steinberg D, Levine E, Askew S, Batch BC, Puleo EM, Svetkey LP, Bosworth HB, DeVries A, Miranda H, Bennett GG. Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients. Contemp Clin Trials. 2016 May;48:12-20. doi: 10.1016/j.cct.2016.03.006. Epub 2016 Mar 17. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |