Project Health Intervention Among Latinx Adults in Primary Care

NCT04090515 | Unknown

• 1 other identifier: STUDY00001757
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

Keywords

Obesity; Eating; Physical Activity; Exercise

Outcome Measures

Primary Outcomes (1)

• Body Mass Index

  Body mass index will be used to assess obesity. For the current study objective height and weight measurements will be obtained from each participant. BMI will be calculated per World Health Organization (WHO) recommendations based on measured weight and height (\[weight (pounds)\]/\[height (inches)2 x 703\]) with lower values indicating better outcomes.

  Assess change from baseline to 3-month follow-up and 1-year follow-up.

Secondary Outcomes (3)

• Eating Disorder Diagnostic Scale

  Assess change from baseline to 3-month follow-up and 1-year follow-up.

• Positive and Negative Affect Schedule

  Assess change from baseline to 3-month follow-up and 1-year follow-up.

• Food Craving Inventory

  Assess change from baseline to 3-month follow-up and 1-year follow-up.

Study Arms (2)

Project Health

EXPERIMENTAL

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.

Behavioral: Project Health

Educational Video Control

PLACEBO COMPARATOR

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

Other: Educational Video Control

Interventions

Project Health BEHAVIORAL

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

Project Health

Educational Video Control OTHER

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

Educational Video Control

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Houston: lead

Study Sites (1)

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

Houston, Texas, 77204, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael J Zvolensky, Ph.D.

  University of Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamella Nizio, B.S.

CONTACT

(713) 743-8056; niziopam@gmail.com

Brooke Kauffman, Ph.D.

CONTACT

bkauffma@central.uh.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: If participant meets eligibility criteria, the participant will be block randomized to one of two conditions: either (1) active (n = 12) or (2) educational video control (n = 6)

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 16, 2019
• Study Start: November 3, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 30, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)