Recruiting

Observational Study

Sponsor:

University of Houston

Code:

NCT04090515

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Interventions

Project Health

Educational Video Control

Study Details

Brief summary:

The proposed study will examine acceptability/feasibility and establish initial estimates of effect sizes of an existing intervention (Project Health) on a sample of young adult Latinx individuals in a primary health care setting. Project Health intervention involves making small, participant-identified, gradually increasing improvements to their dietary intake and exercise.

Conditions

Obesity

Study ID

NCT04090515

Start date

Nov 3, 2021

Status verified date

Nov, 2021

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Self-reported Hispanic/Latino ethnicity
  • Ability to read, write, and communicate in Spanish
  • Report concern about their weight
  • Affirming weight gain within the past year and/or belief that there is room for improvement in diet/exercise habits.

Exclusion Criteria:

  • Limited mental competency
  • Inability to provide, voluntary, written consent
  • Endorsement of current or past psychotic-spectrum symptoms
  • A reported BMI of < 20 or > 30
  • Current diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder
  • Active suicidality.

Study Design

Enrollment

18 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Project Health

Project Health has three aims: 1) encourage participants to explore the costs of obesity, an unhealthy diet, and sedentary behavior and the benefits of physical fitness, a healthy diet, and regular exercise; 2) help participants gradually reduce caloric intake and increase physical activity, such that the participant reaches energy balance (i.e., is not eating more calories than they need); and 3) reduce attitudinal and behavioral risk factors for eating disorders and obesity. The intervention will be administered in Spanish.

placebo comparator: Educational Video Control

The educational video control condition will include an educational video series on obesity in Spanish.

Interventions

Project Health

This intervention involves a one-hour group meeting for six consecutive weeks.

Educational Video Control

This intervention involves a one-hour educational video control viewing for six consecutive weeks.

Primary outcome measure

  • Body Mass Index [ Time Frame: Assess change from baseline to 3-month follow-up and 1-year follow-up. ]

Central Contacts and Locations

Central contacts

Pamella Nizio, B.S.

(713) 743-8056niziopam@gmail.com

Brooke Kauffman, Ph.D.

bkauffma@central.uh.edu

Locations

RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity

Recruiting

Houston, Texas, United States, 77204

Contacts

Pamella Nizio, B.S.

713-743-8056niziopam@gmail.com

Principal Investigator:

Michael J Zvolensky, Ph.D.

More Information

Sponsor

University of Houston

Last update posted

Nov 30, 2021

Last verified

Nov, 2021

Keywords

  • Obesity
  • Eating
  • Physical Activity
  • Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Houston on 2021-11-30.