Clinical trial NCT01827800: New Media Obesity Treatment in Community Health Centers
Official title: New Media Obesity Treatment in Community Health Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: weight loss
primary care
eHealth
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 351
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* At least 1 visit in the previous 12 months to an adult medicine, internal medicine, or family practice provider at a participating community health center
* BMI between 30.0-45.0 kg/m2 and weight ≤ 320 pounds
* Diagnosis of hypertension or diabetes

Exclusion Criteria:

* Current pregnancy
* Pregnancy in previous 12 months
* Heart attack/stroke in previous 2 years
* Active cancer diagnosis
* Current participation in another weight loss study

Primary outcomes:
measure: Weight change
timeFrame: Baseline - 12 months
Secondary outcomes:
measure: The achievement and maintenance of > 5% weight loss
timeFrame: Baseline - 12 months
measure: Diet
timeFrame: Baseline - 12 months
measure: Cardiometabolic risk markers
timeFrame: Baseline - 12 months
measure: Global Framingham risk score
timeFrame: Baseline - 12 months
measure: An evaluation of the intervention's impact and dissemination potential using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework
timeFrame: 12 and 24 months
measure: Physical activity
timeFrame: Baseline -12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Gary Bennett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.