Gender- and Culturally-Sensitive Weight Loss Intervention for Hispanic Males

NCT02783521 | Completed

• 1 other identifier: 1604536275
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to 1) assess the feasibility, acceptability and preliminary efficacy of a gender- and culturally-sensitive weight loss intervention in 48 overweight/obese Hispanic males ages 18-64 over 12 weeks; 2) assess participant characteristics and process measures related to the uptake of mobile-health (mHealth) technology in overweight/obese Hispanic males over 12 weeks; and 3) assess pathologic changes in the liver in Hispanic men enrolled in a 12-week weight loss intervention using a non-invasive MRI as a therapeutic response biomarker.

Conditions

Overweight; Obesity

Keywords

Hispanic men; Weight loss; Diet; Physical activity; Intervention

Outcome Measures

Primary Outcomes (6)

• Study Recruitment: Interest in Participation

  The number of Hispanic men who contact the researchers and express interest in participation.

  Baseline

• Study Recruitment: Screened for Eligibility

  The number of Hispanic men screened for eligibility.

  Baseline

• Study Recruitment: Eligibility

  The number of Hispanic men eligible/ineligible for study inclusion and reason for ineligibility.

  Baseline

• Study Recruitment: Enrollment

  The number of Hispanic men enrolled in the study.

  Baseline

• Retention

  Retention will be measured as the number of participants who remain in the study at 24 weeks, divided by the number enrolled.

  Week 24

• Treatment Satisfaction/Acceptability

  Participants will be asked to rate their overall satisfaction with the intervention at 24 weeks and if they would recommend the program to others. Participants will also be asked questions regarding satisfaction with their overall progress and for changing dietary and PA habits, and weight

  Week 24

Secondary Outcomes (4)

• Change in body weight.

  6, 12, 18, and 24 weeks

• Change in physical activity

  6, 12, 18, and 24 weeks

• Change in dietary intake

  12 and 24 weeks

• Change in liver fat content (intervention only)

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Includes changing eating behaviors, increasing physical activity, and attending regular in-person weight loss meetings for 12 weeks. To support additional weight loss/weight maintenance, participants will receive bi-weekly phone calls across a 12 week follow-up.

Behavioral: Counseling sessions

Wait List Control

OTHER

Wait-list control participants will not receive any intervention for the first 12 weeks. After 12 weeks, participants will receive the weight loss intervention plus mHealth technology support.

Behavioral: Wait List Control

Interventions

Counseling sessions BEHAVIORAL

During the first 12 weeks, intervention participants will attend weekly 30-45-minute individual counseling sessions guided by a trained bilingual Hispanic male lifestyle coach. Counseling sessions will be tailored to the needs of the participants (e.g., evening/weekend sessions, waiting/childcare area). After 12 weeks, intervention group participants will receive bi-weekly phone calls across a 12-week follow-up. Phone calls will last approximately 10 minutes in duration and study staff will follow a script to review current body weight, eating and activity behaviors, and specific barriers for weight loss/maintenance or diet/physical activity behaviors.

Intervention

Wait List Control BEHAVIORAL

After 12 weeks, the wait list control will receive the weight loss intervention plus mHealth technology support. It will include tailored, targeted text messaging and real-time self-monitoring support including beverage tracking cups, which provide the amount of calories users are consuming through beverages on a daily basis, and wearable activity monitors.Behavioral constructs used for the intervention group will be maintained during this intervention delivery thereby ensuring all participants have the appropriate tools to continue weight loss efforts regardless of mHealth use.

Wait List Control

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• BMI between 25 to 45.0 kg/m² (NOTE: The investigators elected to cap this at 45.0 kg/m² to minimize potential risks and to reduce the potential for obesity to limit exercise participation)
• Ability to provide informed consent and health risk assessment prior to participation in this study
• Speak, read, and write either English and/or Spanish

You may not qualify if:

• Uncontrolled diabetes mellitus
• History of bariatric surgery
• Report medical condition or treatment for a medical condition that could affect body weight or ability to engage in structured physical activity that is consistent with the intervention for this study
• Current congestive heart failure, angina, uncontrolled arrhythmia, or other symptoms indicative of an increased acute risk for a cardiovascular event
• Resting systolic blood pressure of ≥150 mmHg or resting diastolic blood pressure of ≥90 mmHg
• Eating disorders that would contraindicate weight loss or physical activity
• Alcohol or substance abuse
• Currently treated for psychological issues (i.e. depression, bipolar disorder, etc.), taking psychotropic medications with the previous 12 months, or hospitalized for depression within the previous 5 years
• Report exercise on ≥3 days per week for ≥ 20 minutes per day over the past 3 months
• Report weight loss of ≥5% or participating in a weight reduction diet program in the past 3 months
• Report plans to relocate to a location that limits their access to the study site or having employment, personal, or travel commitments that prohibit attendance to all of the scheduled assessments

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona Collaboratory for Metabolic Disease Prevention and Treatment

Tucson, Arizona, 85714, United States

Location

Related Publications (7)

• Ogden CL, Carroll MD, Kit BK, Flegal KM. Prevalence of childhood and adult obesity in the United States, 2011-2012. JAMA. 2014 Feb 26;311(8):806-14. doi: 10.1001/jama.2014.732.

  PMID: 24570244 BACKGROUND

• Lindberg NM, Stevens VJ, Halperin RO. Weight-loss interventions for Hispanic populations: the role of culture. J Obes. 2013;2013:542736. doi: 10.1155/2013/542736. Epub 2013 Feb 26.

  PMID: 23533725 BACKGROUND

• Jensen MD, Ryan DH, Apovian CM, Ard JD, Comuzzie AG, Donato KA, Hu FB, Hubbard VS, Jakicic JM, Kushner RF, Loria CM, Millen BE, Nonas CA, Pi-Sunyer FX, Stevens J, Stevens VJ, Wadden TA, Wolfe BM, Yanovski SZ; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; Obesity Society. 2013 AHA/ACC/TOS guideline for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and The Obesity Society. J Am Coll Cardiol. 2014 Jul 1;63(25 Pt B):2985-3023. doi: 10.1016/j.jacc.2013.11.004. Epub 2013 Nov 12. No abstract available.

  PMID: 24239920 BACKGROUND

• Pagoto SL, Schneider KL, Oleski JL, Luciani JM, Bodenlos JS, Whited MC. Male inclusion in randomized controlled trials of lifestyle weight loss interventions. Obesity (Silver Spring). 2012 Jun;20(6):1234-9. doi: 10.1038/oby.2011.140. Epub 2011 Jun 2.

  PMID: 21633403 BACKGROUND

• Garcia DO, Valdez LA, Hooker SP. Hispanic Male's Perspectives of Health Behaviors Related to Weight Management. Am J Mens Health. 2017 Sep;11(5):1547-1559. doi: 10.1177/1557988315619470. Epub 2015 Dec 3.

  PMID: 26634854 BACKGROUND

• Garcia DO, Valdez LA, Aceves B, Bell ML, Rabe BA, Villavicencio EA, Marrero DG, Melton F, Hooker SP. mHealth-Supported Gender- and Culturally Sensitive Weight Loss Intervention for Hispanic Men With Overweight and Obesity: Single-Arm Pilot Study. JMIR Form Res. 2022 Sep 21;6(9):e37637. doi: 10.2196/37637.

  PMID: 36129735 DERIVED

• Garcia DO, Valdez LA, Bell ML, Humphrey K, Hingle M, McEwen M, Hooker SP. A gender- and culturally-sensitive weight loss intervention for Hispanic males: The ANIMO randomized controlled trial pilot study protocol and recruitment methods. Contemp Clin Trials Commun. 2018 Feb 9;9:151-163. doi: 10.1016/j.conctc.2018.01.010. eCollection 2018 Mar.

  PMID: 29696238 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Weight Loss; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Behavior

Study Officials

• David O. Garcia, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: May 26, 2016
• Study Start: May 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: November 1, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)