A Novel Approach to Reducing Adiposity Among Young Men

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Obesity; Weight Loss; Lifestyle Risk Reduction; Men
• Intervention / Treatment: Behavioral: Self-guided lifestyle intervention

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 Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent weight lost	Percent weight change (measured in kg via calibrated scale); calculated as: (post-treatment weight - baseline weight) / baseline weight *100	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): July 26, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Cardiovascular Diseases; Weight Loss
• Other Study ID Numbers: HM20015458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No