An Internet-based Behavioral Weight Loss Program for HIV+ Patients

NCT ID: NCT02421406

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-02-28

Brief Summary

The goal of this project is to determine whether an Internet-based weight loss program will lead to weight loss and improvements in cardiovascular disease risk factors in people living with HIV.

Detailed Description

The goal of this project is to provide an empirically validated weight loss program to HIV+ patients and evaluate its efficacy for weight loss and improvements in cardiovascular disease risk factors. Investigators will conduct a randomized pilot study with 50 overweight or obese patients who are HIV+, are recruited from the Miriam Hospital Immunology Center, and are interested in losing weight. These patients will be randomly assigned to a 12 week behavioral weight loss program delivered via the Internet or to a 12 week education only control group (also Internet based). Primary aims of this study are 1) to determine whether an Internet program is appropriate for this patient population, assessed by the success of recruiting 50 patients for the trial and their level of adherence over the 12 weeks, 2) to compare weight losses at the end of the 12 week program for program for patients randomized to the Internet behavioral weight reduction program (WT LOSS) relative to the Internet education program (CONTROL), 3) to compare the efficacy of the WT LOSS program relative to CONTROL for improving lipids (total cholesterol, HDL, LDL, triglycerides), metabolic measures (fasting blood sugar, insulin), and inflammatory markers (IL-6, C-reactive protein, adiponectin), and 4) to compare the changes in dietary intake and physical activity from baseline to 12 weeks in the WT LOSS and CONTROL conditions. Investigators will also store blood for later analysis of other adipokines (leptin) and biomarkers of microbial gut translocation (e.g., sCD14). These will provide important pilot data for future NIH funding related to both the implementation of weight loss programs and the effect of weight loss on the co-morbidities in this population.

Conditions

Overweight; Obesity; HIV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet Behavioral Intervention

Participants receive a 12-week Internet-based eating and activity intervention including multimedia lessons and enhanced self-monitoring of weight loss behaviors with automated feedback

Group Type: EXPERIMENTAL

Internet Behavioral Intervention

Intervention Type: BEHAVIORAL

A series of 12 multi-media lessons will be accessible to participants on their own computers. The lessons (each of which takes about 15 minutes to complete) are based on the Diabetes Prevention Program (DPP) and Look AHEAD. Participants will be taught to record their weight, the calories and the fat grams in each food item, and their physical activity (in minutes) on a daily basis. At the end of the week, they will submit their self-monitored information to the study website and receive an automated feedback message about their progress to date. The lessons will also present key behavior change strategies such as cognitive restructuring, problem solving and relapse prevention.

Internet Education Intervention

Participants receive 12 weekly Internet-based weight loss lessons containing information for modification of diet and activity behaviors, but not behavioral strategies for changing these behaviors.

Group Type: ACTIVE_COMPARATOR

Internet Education Intervention

Intervention Type: BEHAVIORAL

A series of 12 lessons will be accessible to participants on their own computers. Participants will be given information about normal, overweight and obese categories of body mass index, and provided information on the health problems that are associated with being overweight and the benefits of weight loss for treating and preventing such problems. General information about healthy eating will be provided. Participants will be educated about the benefits of increasing their physical activity, and strategies for increasing activity safely.

Interventions

Internet Behavioral Intervention

A series of 12 multi-media lessons will be accessible to participants on their own computers. The lessons (each of which takes about 15 minutes to complete) are based on the Diabetes Prevention Program (DPP) and Look AHEAD. Participants will be taught to record their weight, the calories and the fat grams in each food item, and their physical activity (in minutes) on a daily basis. At the end of the week, they will submit their self-monitored information to the study website and receive an automated feedback message about their progress to date. The lessons will also present key behavior change strategies such as cognitive restructuring, problem solving and relapse prevention.

Intervention Type: BEHAVIORAL

Internet Education Intervention

A series of 12 lessons will be accessible to participants on their own computers. Participants will be given information about normal, overweight and obese categories of body mass index, and provided information on the health problems that are associated with being overweight and the benefits of weight loss for treating and preventing such problems. General information about healthy eating will be provided. Participants will be educated about the benefits of increasing their physical activity, and strategies for increasing activity safely.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Recruited from the Miriam Hospital Immunology Center
• HIV+ with a CD4 count >200 and an undetectable viral load
• BMI greater than 27 kg/m2
• No health problems that make weight loss or unsupervised exercise unsafe
• English speaking
• Have access to a computer and the Internet

Exclusion Criteria

• Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire
• Active substance abuser
• Currently pregnant or intend to become pregnant in the next 6 months
• Planning to move outside of the state within the next 6 months
• Have participated in a study conducted by the Weight Control & Diabetes Research Center in the past 2 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brown University

OTHER

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

The Miriam Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Wing RR, Becofsky K, Wing EJ, McCaffery J, Boudreau M, Evans EW, Unick J. Behavioral and Cardiovascular Effects of a Behavioral Weight Loss Program for People Living with HIV. AIDS Behav. 2020 Apr;24(4):1032-1041. doi: 10.1007/s10461-019-02503-x.

Reference Type: DERIVED

PMID: 31004243 (View on PubMed)

Becofsky K, Wing EJ, McCaffery J, Boudreau M, Wing RR. A Randomized Controlled Trial of a Behavioral Weight Loss Program for Human Immunodeficiency Virus-Infected Patients. Clin Infect Dis. 2017 Jul 1;65(1):154-157. doi: 10.1093/cid/cix238.

Reference Type: DERIVED

PMID: 28369269 (View on PubMed)

Other Identifiers

P30AI042853

Identifier Type: NIH

Identifier Source: secondary_id

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2P30AI042853-16

Identifier Type: NIH

Identifier Source: org_study_id

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