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Rethinking Eating and FITness for Men (REFIT)

Primary Purpose

Weight Loss, Overweight

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
REFIT Intervention
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Male
  • 18-65 years of age
  • Body mass index between 25-40 kg/m²
  • Able to access the Internet at least twice weekly
  • Able to read and write in English
  • Able to attend two group sessions at the UNC Weight Research Program clinic site

Exclusion Criteria:

  • Lost more than 10 pounds over the last 6 months
  • Currently participating in another weight loss program
  • Report a diagnosis of schizophrenia, bipolar disorder, or substance abuse, or depression leading to hospitalization during the previous year
  • Currently being treated for cancer
  • Unable to exercise safely (as defined as endorsement of items 1-4 of the Physical Activity Readiness Questionnaire)
  • Heavy use or abuse of alcohol (as defined as a score of 8 or higher on the Alcohol Disorders Identification Test)

Sites / Locations

  • University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

REFIT Intervention

Wait-list control

Arm Description

This arm will receive the REFIT intervention immediately after randomization.

This arm will receive a modified version of the REFIT program after the 6-month assessment.

Outcomes

Primary Outcome Measures

Change in weight from baseline to 3 months
Weight will be collected at baseline and 3 months at the UNC Weight Research Program Center and measured to the nearest 0.1 kg using a digital Tanita scale that will be calibrated routinely. Participants will weigh-in wearing shorts and no shoes.

Secondary Outcome Measures

Change in weight from baseline to 6 months
Weight will be collected at baseline and 6 months at the UNC Weight Research Program Center and measured to the nearest 0.1 kg using a digital Tanita scale that will be calibrated routinely. Participants will weigh-in wearing shorts and no shoes.
Change in caloric intake between baseline and 3 months
Caloric intake will be assessed at baseline and 3 months using the online Automated Self-Administered 24-hour recall tool created by the National Cancer Institute.
Change in physical activity between baseline and 3 months
Energy expenditure from exercise will be assessed at baseline and 3 months via the Paffenbarger Exercise Habits Questionnaire.
Self-efficacy for weight loss behaviors at 3 months
Self-efficacy for eating behaviors related to weight control will be measured at 3 months using the Weight Efficacy Lifestyle Questionnaire.
Motivation for healthy eating at 3 months
Motivation for healthy eating will be measured at 3 months using the Treatment Self-Regulation Questionnaire for Healthy Eating.
Motivation for Physical Activity at 3 months
Motivation for physical activity will be measured at 3 months using the Treatment Self-Regulation Questionnaire for Physical Activity.

Full Information

First Posted
April 26, 2013
Last Updated
October 20, 2014
Sponsor
University of North Carolina, Chapel Hill
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1. Study Identification

Unique Protocol Identification Number
NCT01843595
Brief Title
Rethinking Eating and FITness for Men
Acronym
REFIT
Official Title
Efficacy Trial of the REFIT (Rethinking Eating and FITness) Weight Loss Intervention for Men
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to test the effect of a new three-month behavioral weight loss program among adult men. Weight will be measured at three and six months post randomization. The intervention will be compared to a wait-list control group. Participants will be 112 overweight and obese men (18-65) living in the Chapel Hill/Raleigh/Durham area. The behavioral intervention tested will be delivered online with two face-to-face group meetings. Intervention content will be delivered via email and online. It is hypothesized that men randomized to the REFIT intervention will lose more weight at 3 months than men randomized to the wait-list group.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Overweight

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REFIT Intervention
Arm Type
Experimental
Arm Description
This arm will receive the REFIT intervention immediately after randomization.
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
This arm will receive a modified version of the REFIT program after the 6-month assessment.
Intervention Type
Behavioral
Intervention Name(s)
REFIT Intervention
Intervention Description
The intervention will include 2 face-to-face group meetings, weekly check-in sessions, weekly tailored feedback, and weekly lessons focused on specific weight loss behaviors. All participants will be encouraged increase their physical activity to approximately 250 minutes of moderate to vigorous physical activity per week.
Primary Outcome Measure Information:
Title
Change in weight from baseline to 3 months
Description
Weight will be collected at baseline and 3 months at the UNC Weight Research Program Center and measured to the nearest 0.1 kg using a digital Tanita scale that will be calibrated routinely. Participants will weigh-in wearing shorts and no shoes.
Time Frame
Baseline, 3 months
Secondary Outcome Measure Information:
Title
Change in weight from baseline to 6 months
Description
Weight will be collected at baseline and 6 months at the UNC Weight Research Program Center and measured to the nearest 0.1 kg using a digital Tanita scale that will be calibrated routinely. Participants will weigh-in wearing shorts and no shoes.
Time Frame
Baseline, 6 months
Title
Change in caloric intake between baseline and 3 months
Description
Caloric intake will be assessed at baseline and 3 months using the online Automated Self-Administered 24-hour recall tool created by the National Cancer Institute.
Time Frame
Baseline, 3 months
Title
Change in physical activity between baseline and 3 months
Description
Energy expenditure from exercise will be assessed at baseline and 3 months via the Paffenbarger Exercise Habits Questionnaire.
Time Frame
Baseline, 3 months
Title
Self-efficacy for weight loss behaviors at 3 months
Description
Self-efficacy for eating behaviors related to weight control will be measured at 3 months using the Weight Efficacy Lifestyle Questionnaire.
Time Frame
3 months
Title
Motivation for healthy eating at 3 months
Description
Motivation for healthy eating will be measured at 3 months using the Treatment Self-Regulation Questionnaire for Healthy Eating.
Time Frame
3 months
Title
Motivation for Physical Activity at 3 months
Description
Motivation for physical activity will be measured at 3 months using the Treatment Self-Regulation Questionnaire for Physical Activity.
Time Frame
3 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male 18-65 years of age Body mass index between 25-40 kg/m² Able to access the Internet at least twice weekly Able to read and write in English Able to attend two group sessions at the UNC Weight Research Program clinic site Exclusion Criteria: Lost more than 10 pounds over the last 6 months Currently participating in another weight loss program Report a diagnosis of schizophrenia, bipolar disorder, or substance abuse, or depression leading to hospitalization during the previous year Currently being treated for cancer Unable to exercise safely (as defined as endorsement of items 1-4 of the Physical Activity Readiness Questionnaire) Heavy use or abuse of alcohol (as defined as a score of 8 or higher on the Alcohol Disorders Identification Test)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa M Crane, MA
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deborah F. Tate, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Director
Facility Information:
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26842133
Citation
Crane MM, Ward DS, Lutes LD, Bowling JM, Tate DF. Theoretical and Behavioral Mediators of a Weight Loss Intervention for Men. Ann Behav Med. 2016 Jun;50(3):460-70. doi: 10.1007/s12160-016-9774-z.
Results Reference
derived

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Rethinking Eating and FITness for Men

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