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Weight LossNCT03037502

Tailoring a Lifestyle Intervention to Address Obesity Disparities Among Men

A study testing Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud) in people with Weight Loss and Obesity, run by Vanderbilt University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

If the investigators are to adequately address the health needs of African American and Latino men, both culture and gender must be considered when developing and implementing strategies to encourage weight loss and increase their healthy eating and physical activity.The aim of this project is to develop and test… Read more about this study

Who is it for?
Ages 35 to 64 years, men only
Conditions the study is for
Weight Loss, Obesity
What is being tested?
Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
2 sitesUnited States
Study dates
12 Jun 2019to 31 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 64 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age: 35-64 at enrollment
  • Race/ ethnicity: African American/ Black or Latino/ Hispanic
  • BMI: 27-50
  • Fluent in English (Nashville and Miami) or Spanish (Miami)
  • Provide informed consent
  • Weight less than 400 pounds

Who cannot join

  • Preexisting condition that prohibits at least moderate physical activity
  • Serious medical condition that is likely to hinder accurate measurement of weight, for which weight loss is contraindicated or that would cause weight loss
  • Prior or planned bariatric surgery
  • Chronic use of medications that are likely to cause weight gain or cause weight loss
  • No cell phone or land-line phone
  • Participant in another obesity, eating or physical activity program or study
  • Psychiatric hospitalization or in-patient substance abuse treatment in the last 12 months

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Miami

    Miami, Florida, 33136

  • Vanderbilt University

    Nashville, Tennessee, 37203

Other trials in United States

About this study

If the investigators are to adequately address the health needs of African American and Latino men, both culture and gender must be considered when developing and implementing strategies to encourage weight loss and increase their healthy eating and physical activity.The aim of this project is to develop and test gendered, culturally and contextually relevant messages that will be used in a future, web- based tailored intervention to encourage healthy eating and physical activity in African American and Latino men. This study is part of a larger research agenda that for a decade has focused on understanding and reducing chronic disease risk among African American and Latino men. Because men are more likely than women to engage in over 30 behaviors known to increase their risk of injury, morbidity, and mortality, improving men's health requires understanding the social and cultural factors that help explain sex differences in health. Operationalizing gender in individually-tailored health communications has great potential to unlock the potential of health communications and interventions to engage and improve the health of men and particularly African American and Latino men. To date, no community-based intervention has produced clinically significant improvements in weight loss, healthy eating or physical activity in Latino and African American men. It also is unclear how technology can be used to promote these behaviors in this population. Thus, there is a need to develop healthy eating, physical activity and weight loss interventions specifically targeted and tailored to African American and Latino men that explores the utility of technology. This intervention content and focus represents a novel strategy to promote health equity by using technology-based health care innovations to improve healthy eating and active living by addressing a root cause of unhealthy behavior in men: notions of manhood. The investigators focus on gender and manhood because they are under-explored factors that shape men's health behaviors.

Read the detailed description

The overall aim of this study is to develop and pilot an individualized weight-loss intervention for obese middle-aged African American and Latino men and to explore how the genetically predicted BMI relates to outcomes. Using strategies previously employed by the PI to develop individually-tailored materials for African American men, the proposed study is designed to develop person-specific materials for Latino men (Specific Aim 1). Investigators also will pilot a behavioral weight loss intervention for 35-64 year old African American men in Nashville and Latino men in Miami (Specific Aims 2-3), and explore how the phenotypic expression of obesity shapes and is affected by behavioral and physiological changes (Specific Aim 4). The proposed intervention includes (a) person-specific goals/ messages (via web and text), (b) self-monitoring (via wearable device and text), (c) small group training and education (including social support) and (d) educational and community-based information and resources (via web and text).

Conditions
Weight Loss, Obesity
Being tested
Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud)
Keywords
Men's Health, weight loss, African American men, Latino men
Medical subject headings
Weight Loss, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud)Behavioural

    Assess the effectiveness of a person-specific, randomized controlled pilot weight loss study of 80 African American and 40 Latino men; to compare changes in chronic disease risk behaviors (e.g., diet and physical activity), adiposity measures (e.g., body fat), and psychosocial mediators (e.g., social support, autonomous motivation) between data collected at baseline and at 3-months.

Study groups in NCT03037502
Study groupRoleWhat they receive
Intervention: Tailor MadeExperimentalIntervention Arm: In the pilot intervention, participants will receive: tailored goals/ messages, self-monitoring, weekly small groups to receive health education and community-based information and resources. Participants will also complete two assessment with blood work and anthropometric measurements. These intervention components were selected based on investigator's formative research and experience using them in prior studies. These components will be implemented simultaneously as they complement one another. While all of these components have not been tested together in an intervention for this population, they are variations and enhancements of previous interventions by the investigators.
Receives: Behavioral: Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud)
ComparisonNo interventionComparison Condition: Participants in the attention control group will receive self-help materials on how to improve healthy eating, physical activity and weight loss, self-monitoring, and complete two assessments with blood work and anthropometric measurements. Participants in this condition will receive a copy of their assessment data and the nurses will provide this personalized information as well as answer any questions participants may have about their assessment results.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in weight at 3-months post-baseline

    Investigators will report weight change in absolute terms from baseline.

    Measured: 3-months post-baseline of participation

Secondary outcomes (2)

  1. Percent change in weight at 3-months post-baseline

    Investigators will report weight change as percent change from baseline.

    Measured: 3-months post-baseline of participation

  2. Change in weight classification

    Investigators will assess change in percentage of participants that regress from obese to overweight classification using BMI in kg/m^2.

    Measured: 3-months post baseline of participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2017 (estimated)
  2. Study start12 Jun 2019
  3. Primary completion31 Mar 2021
  4. Study completion31 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03037502
Sponsor's protocol ID
160108
Other IDs
1U54MD010722
Status last verified
Apr 2021
First submitted
26 Jan 2017
Last updated
23 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Griffith DM, Jaeger EC, Valdez LA, Schaefer Solle N, Garcia DO, Alexander LR. Developing a "Tailor-Made" Precision Lifestyle Medicine Intervention for Weight Control among Middle-aged Latino Men. Ethn Dis. 2020 Apr 2;30(Suppl 1):203-210. doi: 10.18865/ed.30.S1.203. eCollection 2020.

    PubMed 32269462

  • Griffith DM, Jaeger EC, Pennings JS, Semlow AR, Ellison JM, Alexander LR. Tailor Made: A Pilot Virtual Weight Loss Intervention Individually Tailored for African American Men. Health Promot Pract. 2025 May;26(3):529-543. doi: 10.1177/15248399231213347. Epub 2023 Dec 5.

    PubMed 38050903

Questions about this trial

What is this clinical trial studying?

A study testing Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud) in people with Weight Loss and Obesity, run by Vanderbilt University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in weight at 3-months post-baseline (time frame: 3-months post-baseline of participation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03037502, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2021.

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