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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed Treatment Control group | No Intervention | Participants will receive the treatment after completion of the 3-month follow-up assessment | |
| Lifestyle group | Experimental | Participants will receive the treatment immediately |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Self-identified males
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| Name | Affiliation | Role |
|---|---|---|
| Jessica G LaRose, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University School of Medicine | Richmond | Virginia | 23298 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38578686 | Derived | Reading JM, Crane MM, Guan J, Jackman R, Thomson MD, LaRose JG. Acceptability of a Self-Guided Lifestyle Intervention Among Young Men: Mixed Methods Analysis of Pilot Findings. JMIR Form Res. 2024 Apr 5;8:e53841. doi: 10.2196/53841. | |
| 36846742 | Derived | Reading JM, Crane MM, Carlyle K, Perera RA, LaRose JG. A Self-Guided Lifestyle Intervention for Young Men: Findings from the ACTIVATE Randomized Pilot Trial. J Mens Health. 2022;18(9):191. doi: 10.31083/j.jomh1809191. Epub 2022 Sep 14. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 18, 2020 | Jul 19, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| D018761 | Multiple Endocrine Neoplasia Type 1 |
| D040242 | Risk Reduction Behavior |
| D002318 | Cardiovascular Diseases |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
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 |
| D009377 | Multiple Endocrine Neoplasia |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009378 | Neoplasms, Multiple Primary |
| D009386 | Neoplastic Syndromes, Hereditary |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |