New Media Obesity Treatment in Community Health Centers

• ClinicalTrials.gov Identifier: NCT01827800
• Recruitment Status: Completed
• First Posted: April 10, 2013
• Last Update Posted: August 13, 2018
• Sponsor: Duke University
• Information provided by (Responsible Party): Duke University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Obesity	Behavioral: eHealth weight loss intervention	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 351 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: New Media Obesity Treatment in Community Health Centers
• Actual Study Start Date: June 2013
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: July 31, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: eHealth weight loss intervention; 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; 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.
No Intervention: Usual care; Participants in the usual care arm will receive the usual primary care services offered by their community health center primary care providers.

Outcome Measures

Primary Outcome Measures :

1. Weight change [ Time Frame: Baseline - 12 months ]
   Weight will be measured at baseline and 12 months using a SECA 876 scale.

Secondary Outcome Measures :

1. The achievement and maintenance of > 5% weight loss [ Time Frame: Baseline - 12 months ]
   Weight will be measured at baseline and 12 months using a SECA 876 scale.
2. Diet [ Time Frame: Baseline - 12 months ]
   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.
3. Cardiometabolic risk markers [ Time Frame: Baseline - 12 months ]
   Risk markers include waist circumference, systolic and diastolic blood pressure, lipid panel and A1c levels
4. Global Framingham risk score [ Time Frame: Baseline - 12 months ]
   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.
5. An evaluation of the intervention's impact and dissemination potential using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework [ Time Frame: 12 and 24 months ]
   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.
6. Physical activity [ Time Frame: Baseline -12 months ]
   Physical activity will be measured at baseline and 12 months using the GPAQ (the Global Physical Activity Questionnaire developed by the World Health Organization).

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27705

Sponsors and Collaborators

Duke University

Investigators

• Principal Investigator: Gary Bennett, PhD; Duke University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

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.

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.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT01827800
• Other Study ID Numbers: B0033
• First Posted: April 10, 2013
• Last Update Posted: August 13, 2018
• Last Verified: August 2018

Keywords provided by Duke University:

weight loss; primary care; eHealth

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight