A Novel Approach to Reducing Adiposity Among Young Men

• ClinicalTrials.gov Identifier: NCT04267263
• Recruitment Status: Completed
• First Posted: February 12, 2020
• Last Update Posted: July 26, 2021
• Sponsor: Virginia Commonwealth University
• Information provided by (Responsible Party): Virginia Commonwealth University

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.

Condition or disease	Intervention/treatment	Phase
Weight Loss; Men; Lifestyle Risk Reduction; Cardiovascular Diseases; Obesity	Behavioral: Self-guided lifestyle intervention	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Novel Approach to Reducing Adiposity Among Young Men
• Actual Study Start Date: January 20, 2021
• Actual Primary Completion Date: July 1, 2021
• Actual Study Completion Date: July 1, 2021

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Delayed Treatment Control group; Participants will receive the treatment after completion of the 3-month follow-up assessment
Experimental: Lifestyle group; Participants will receive the treatment immediately	Behavioral: Self-guided lifestyle intervention; 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.

Outcome Measures

Primary Outcome Measures :

1. Percent weight lost [ Time Frame: 3 months ]
   Percent weight change (measured in kg via calibrated scale); calculated as: (post-treatment weight - baseline weight) / baseline weight *100

Secondary Outcome Measures :

1. Change in perceived risk for heart disease [ Time Frame: Baseline to 3 months ]
   Perceived risk assessed via 12-item Risk Behavior Diagnosis scale
2. Change in minutes of moderate to vigorous physical activity [ Time Frame: Baseline to 3 months ]
   Physical activity assessed via 21-item Global Physical Activity Questionnaire
3. Change in diet quality [ Time Frame: Baseline to 3 months ]
   Dietary habits assessed via 26-item National Cancer Institute's Dietary Screening Questionnaire
4. Change in sleep quality [ Time Frame: Baseline to 3 months ]
   Sleep habits assessed via 6-item Common Elements Sleep Quesitonnaire

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Self-identified males
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. self-identify as a man
2. 18-35 years old
3. BMI 25-45kg/m2
4. Live in North America

Exclusion Criteria:

1. an uncontrolled medical condition that might make it unsafe to change their eating or engage in unsupervised physical activity (e.g., uncontrolled hypertension)
2. a diagnosis of Type 1 or Type 2 diabetes
3. 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
4. currently enrolled in another weight loss program, taking weight loss medication or history of weight loss surgery
5. change in medication(s) within the last 3 months that could influence weight (e.g., steroids)
6. have lost > 5% body weight within the last 3 months
7. report a history of anorexia nervosa or bulimia nervosa or any compensatory behaviors within the previous 3 months
8. report hospitalization for a psychiatric condition within the last year
9. report high alcohol intake (AUDIT score > 16).
10. are not able to speak and read English
11. do not possess a mobile device or are unwilling to use it to receive study text messages
12. 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).

Contacts and Locations

Locations

United States, Virginia

Virginia Commonwealth University School of Medicine

Richmond, Virginia, United States, 23298

Sponsors and Collaborators

Virginia Commonwealth University

Investigators

• Principal Investigator: Jessica G LaRose, PhD; Virginia Commonwealth University

  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:

Informed Consent Form  [PDF] November 18, 2020

More Information

• Responsible Party: Virginia Commonwealth University
• ClinicalTrials.gov Identifier: NCT04267263
• Other Study ID Numbers: HM20015458
• First Posted: February 12, 2020
• Last Update Posted: July 26, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Cardiovascular Diseases; Weight Loss; Body Weight Changes; Body Weight