New Media Obesity Treatment in Community Health Centers

NCT01827800 | Completed DMC

• 1 other identifier: B0033
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

weight loss; primary care; eHealth

Outcome Measures

Primary Outcomes (1)

• Weight change

  Weight will be measured at baseline and 12 months using a SECA 876 scale.

  Baseline - 12 months

Secondary Outcomes (6)

• The achievement and maintenance of > 5% weight loss

  Baseline - 12 months

• Diet

  Baseline - 12 months

• Cardiometabolic risk markers

  Baseline - 12 months

• Global Framingham risk score

  Baseline - 12 months

• An evaluation of the intervention's impact and dissemination potential using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework

  12 and 24 months

Study Arms (2)

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.

Behavioral: eHealth weight loss intervention

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.

Interventions

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.

eHealth weight loss intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

Location

Related Publications (5)

• 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.

  PMID: 32985131 DERIVED

• 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.

  PMID: 30905430 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.

  PMID: 30891688 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.

  PMID: 30361140 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.

  PMID: 26995281 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Gary Bennett, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2013
• First Posted: April 10, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: July 31, 2018
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

US (1)