Completed

REFITEfficacy Trial of the REFIT (Rethinking Eating and FITness) Weight Loss Intervention for Men

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What is being tested

REFIT Intervention

Behavioral
Who is being recruted

Body Weight+6

+ Body Weight Changes

+ Nutrition Disorders

From 18 to 65 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2013
See protocol details

Summary

Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: October 21, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2013

Actual date on which the first participant was enrolled.

Obesity is one of the greatest threats to modern public health. It is associated with negative physical and mental health outcomes as well as increased healthcare expenditures. Throughout the time period that the prevalence of overweight and obesity have been monitored in the United States, men have consistently been more likely than women to be overweight and; conversely, women have been more likely to be obese. Recent trends suggest that this situation may be changing. Over the past decade, the prevalence of obesity has increased among men while it has stabilized among women. For the first time, men and women have near equal rates of obesity where approximately 35.7% of American adults are classified as obese; meanwhile, men continue to be more overweight than women. The epidemiological trends have lead to a focus on creating weight loss programs that can aid overweight and obese adults in losing excess weight. Behavioral interventions for obesity have demonstrated the ability to produce weight losses of approximately 5-10% of initial body weight. These weight losses have been associated with decreased risk for type II diabetes, reduced blood pressure, and improvement in mental health outcomes. Unfortunately, men typically do not take advantage of such programs. Across multiple literature reviews, men consistently make up approximately 27% of study samples. This has lead to a situation where researchers have little information about how to enroll men in weight loss programs and what kind of programs are of interest to men. In order to combat the increased obesity in men and help them to avoid the negative consequences of obesity, it is important to help overweight and obese men change their eating and physical activity habits within the context of organized weight loss programs. The REFIT (Rethinking Eating and FITness) intervention is an intervention developed to address men's needs for weight loss while balancing their need to perform behaviors which are seen as masculine. Men typically eat a diet that is associated with weight gain rather than weight loss. The REFIT intervention will focus on changing eating and exercise behaviors within a structured weight loss program that will allow men to maintain their autonomy. Autonomy is a central characteristic of enacted masculinity and has been described in qualitative research as a necessary aspect of a weight loss program for men. The intervention will focus on encouraging changes in eating and activity through increasing self-efficacy, autonomous motivation, outcome expectancies, and self-regulation for weight loss behaviors. The development of this intervention has been guided by qualitative research focused on what men want and need from weight loss programs as well as previous research focused on weight loss among both men and women. The approach to be used in the REFIT intervention is innovative as a combination of the "small changes" approach that has been used in weight gain prevention as well as the client centered deficit approaches used by Lutes and colleagues and Sbrocco and colleagues in weight loss programs.

Principal SponsorUniversity of North Carolina, Chapel Hill
Last updated: October 21, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

107 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightBody Weight ChangesNutrition DisordersNutritional and Metabolic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionWeight LossOverweight

Criteria

6 inclusion criteria required to participate
18-65 years of age

Able to access the Internet at least twice weekly

Able to attend two group sessions at the UNC Weight Research Program clinic site

Able to read and write in English

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6 exclusion criteria prevent from participating
Currently being treated for cancer

Currently participating in another weight loss program

Heavy use or abuse of alcohol (as defined as a score of 8 or higher on the Alcohol Disorders Identification Test)

Lost more than 10 pounds over the last 6 months

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
This arm will receive the REFIT intervention immediately after randomization.

Group II

No Intervention
This arm will receive a modified version of the REFIT program after the 6-month assessment.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of North Carolina at Chapel Hill

Chapel Hill, United StatesOpen University of North Carolina at Chapel Hill in Google Maps
CompletedOne Study Center