Skip to main content
OpenTrials
Completed

NCT Number: NCT04267263

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Weight Loss Behavior Body Weight Body Weight Changes Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Lifestyle Risk Reduction Men Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Risk Reduction Behavior Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University School of Medicine

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Self-guided lifestyle intervention

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 12, 2020
Registry last updated
Jul 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.