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A Novel Approach to Reducing Adiposity Among Young Men

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04267263
Recruitment Status : Completed
First Posted : February 12, 2020
Last Update Posted : July 26, 2021
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04267263

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United States, Virginia
Virginia Commonwealth University School of Medicine
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
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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

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04267263    
Other Study ID Numbers: HM20015458
First Posted: February 12, 2020    Key Record Dates
Last Update Posted: July 26, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Weight Loss
Body Weight Changes
Body Weight