NCT01843595

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 21, 2014

Status Verified

September 1, 2014

Enrollment Period

1.2 years

First QC Date

April 26, 2013

Last Update Submit

October 20, 2014

Conditions

Weight LossOverweight

Outcome Measures

Primary Outcomes (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.

    Baseline, 3 months

Secondary Outcomes (6)

  • Change in weight from baseline to 6 months

    Baseline, 6 months

  • Change in caloric intake between baseline and 3 months

    Baseline, 3 months

  • Change in physical activity between baseline and 3 months

    Baseline, 3 months

  • Self-efficacy for weight loss behaviors at 3 months

    3 months

  • Motivation for healthy eating at 3 months

    3 months

  • +1 more secondary outcomes

Study Arms (2)

REFIT Intervention

EXPERIMENTAL

This arm will receive the REFIT intervention immediately after randomization.

Behavioral: REFIT Intervention

Wait-list control

NO INTERVENTION

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

Interventions

REFIT InterventionBEHAVIORAL

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.

REFIT Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • 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.

    PMID: 26842133DERIVED

MeSH Terms

Conditions

Weight LossOverweight

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Melissa M Crane, MA

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

  • Deborah F. Tate, PhD

    University of North Carolina, Chapel Hill

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2013

First Posted

April 30, 2013

Study Start

July 1, 2013

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

October 21, 2014

Record last verified: 2014-09

Locations

US(1)