Back to resultsA Novel Approach to Reducing Adiposity Among Young Men
Primary Purpose
Weight Loss, Men, Lifestyle Risk Reduction
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-guided lifestyle intervention
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss
Eligibility Criteria
Inclusion Criteria:
- self-identify as a man
- 18-35 years old
- BMI 25-45kg/m2
- Live in North America
Exclusion Criteria:
- an uncontrolled medical condition that might make it unsafe to change their eating or engage in unsupervised physical activity (e.g., uncontrolled hypertension)
- a diagnosis of Type 1 or Type 2 diabetes
- report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q), which will be administered during prescreen
- currently enrolled in another weight loss program, taking weight loss medication or history of weight loss surgery
- change in medication(s) within the last 3 months that could influence weight (e.g., steroids)
- have lost > 5% body weight within the last 3 months
- report a history of anorexia nervosa or bulimia nervosa or any compensatory behaviors within the previous 3 months
- report hospitalization for a psychiatric condition within the last year
- report high alcohol intake (AUDIT score > 16).
- are not able to speak and read English
- do not possess a mobile device or are unwilling to use it to receive study text messages
- Given strict data regulations outside of North America (i.e., Europe), we will only include participants living in North America (i.e., United States, Canada).
Sites / Locations
- Virginia Commonwealth University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Delayed Treatment Control group
Lifestyle group
Arm Description
Participants will receive the treatment after completion of the 3-month follow-up assessment
Participants will receive the treatment immediately
Outcomes
Primary Outcome Measures
Percent weight lost
Percent weight change (measured in kg via calibrated scale); calculated as: (post-treatment weight - baseline weight) / baseline weight *100
Secondary Outcome Measures
Change in perceived risk for heart disease
Perceived risk assessed via 12-item Risk Behavior Diagnosis scale
Change in minutes of moderate to vigorous physical activity
Physical activity assessed via 21-item Global Physical Activity Questionnaire
Change in diet quality
Dietary habits assessed via 26-item National Cancer Institute's Dietary Screening Questionnaire
Change in sleep quality
Sleep habits assessed via 6-item Common Elements Sleep Quesitonnaire
Full Information
NCT ID
NCT04267263
First Posted
February 10, 2020
Last Updated
July 19, 2021
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT04267263
Brief Title
A Novel Approach to Reducing Adiposity Among Young Men
Official Title
A Novel Approach to Reducing Adiposity Among Young Men
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this research study is to find out whether a primarily self-guided program can produce changes in weight, body fat and cardiovascular risk among young men.
Detailed Description
This self-guided lifestyle intervention may help men to reduce weight and improve heart health because it has been adapted to meet the possible weight loss needs of young men. Young men may experience reductions in body weight after enrollment in the intervention, but this is unknown.
Study participation lasts approximately 3 months. Participants will be assessed by the study staff and fill out questionnaires about current lifestyle practices (diet, physical activity, sleep habits, risk behaviors). Weight, medical events, and medication use within the last 3 months will be assessed. Eligible participants will be randomly assigned (like the flip of a coin) to the control group or self-guided group.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Men, Lifestyle Risk Reduction, Cardiovascular Diseases, Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Delayed Treatment Control group
Arm Type
No Intervention
Arm Description
Participants will receive the treatment after completion of the 3-month follow-up assessment
Arm Title
Lifestyle group
Arm Type
Experimental
Arm Description
Participants will receive the treatment immediately
Intervention Type
Behavioral
Intervention Name(s)
Self-guided lifestyle intervention
Intervention Description
The intervention will consist of one 60-minute group based online session, adapted specifically for young men based previous work with young adults, followed by a self-guided program for 12-weeks. Participants will receive a tool kit that includes evidence-based resources (scale for self-weighing, handouts that will include free self-monitoring apps and strategies for no-cost exercise, sample meal plans and meal planning tips, and tips for healthy living that emphasize risk areas) to assist them during the self-guided phase, as well as weekly health risk text messages.
Primary Outcome Measure Information:
Title
Percent weight lost
Description
Percent weight change (measured in kg via calibrated scale); calculated as: (post-treatment weight - baseline weight) / baseline weight *100
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in perceived risk for heart disease
Description
Perceived risk assessed via 12-item Risk Behavior Diagnosis scale
Time Frame
Baseline to 3 months
Title
Change in minutes of moderate to vigorous physical activity
Description
Physical activity assessed via 21-item Global Physical Activity Questionnaire
Time Frame
Baseline to 3 months
Title
Change in diet quality
Description
Dietary habits assessed via 26-item National Cancer Institute's Dietary Screening Questionnaire
Time Frame
Baseline to 3 months
Title
Change in sleep quality
Description
Sleep habits assessed via 6-item Common Elements Sleep Quesitonnaire
Time Frame
Baseline to 3 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Self-identified males
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
self-identify as a man
18-35 years old
BMI 25-45kg/m2
Live in North America
Exclusion Criteria:
an uncontrolled medical condition that might make it unsafe to change their eating or engage in unsupervised physical activity (e.g., uncontrolled hypertension)
a diagnosis of Type 1 or Type 2 diabetes
report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q), which will be administered during prescreen
currently enrolled in another weight loss program, taking weight loss medication or history of weight loss surgery
change in medication(s) within the last 3 months that could influence weight (e.g., steroids)
have lost > 5% body weight within the last 3 months
report a history of anorexia nervosa or bulimia nervosa or any compensatory behaviors within the previous 3 months
report hospitalization for a psychiatric condition within the last year
report high alcohol intake (AUDIT score > 16).
are not able to speak and read English
do not possess a mobile device or are unwilling to use it to receive study text messages
Given strict data regulations outside of North America (i.e., Europe), we will only include participants living in North America (i.e., United States, Canada).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica G LaRose, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University School of Medicine
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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A Novel Approach to Reducing Adiposity Among Young Men
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