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Weight LossREFITNCT01843595

Rethinking Eating and FITness for Men

A study testing REFIT Intervention in people with Weight Loss and Overweight, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Weight Loss, Overweight
What is being tested?
REFIT Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
1 siteUnited States
Study dates
Jul 2013to Oct 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Efficacy Trial of the REFIT (Rethinking Eating and FITness) Weight Loss Intervention for Men

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.

Read the 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.

Being tested
REFIT Intervention
Medical subject headings
Weight Loss, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REFIT InterventionBehavioural

    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.

Study groups in NCT01843595
Study groupRoleWhat they receive
REFIT InterventionExperimentalThis arm will receive the REFIT intervention immediately after randomization.
Receives: Behavioral: REFIT Intervention
Wait-list controlNo interventionThis arm will receive a modified version of the REFIT program after the 6-month assessment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 3 months

Secondary outcomes (6)
  1. 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.

    Measured: Baseline, 6 months

  2. 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.

    Measured: Baseline, 3 months

  3. 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.

    Measured: Baseline, 3 months

  4. 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.

    Measured: 3 months

  5. 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.

    Measured: 3 months

  6. 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.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionSep 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01843595
Sponsor's protocol ID
13-1548
Acronym
REFIT
Status last verified
Sep 2014
First submitted
26 Apr 2013
Last updated
21 Oct 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26842133

Questions about this trial

What is this clinical trial studying?

A study testing REFIT Intervention in people with Weight Loss and Overweight, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in weight from baseline to 3 months (time frame: Baseline, 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01843595, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2014.

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