Project Health Intervention Among Latinx Adults in Primary Care

Not Applicable

• Conditions: Obesity
• Interventions: Other: Educational Video Control; Behavioral: Project Health

• Registration Number: NCT04090515
• Lead Sponsor: University of Houston

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.

Detailed Description

The primary goal of the research study is to investigate the acceptability/feasibility and establish initial estimates of effect sizes of Project Health that addresses dietary intake and exercise to reduce BMI, eating disorder symptoms, negative affect, and food cravings at post-intervention. To address this aim, the research will involve a randomized control trial that will employ a longitudinal experimental design that will involve: (a) phone-screener (pre-screener); (b) baseline appointment consisting of a pre-intervention assessment (eligibility); (c) 6-week intervention (randomized to Project Health or Video Control); (d) 3-month follow-up, (e) 1-year follow-up.

Study Timeline

• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-16
• Status Verified: 2021-11
• Study Start: 2021-11-03
• Last Update Submitted: 2021-11-23
• Last Update Posted: 2021-11-30
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational Video Control	Educational Video Control	The educational video control condition will include an educational video series on obesity in Spanish.
Project Health	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.

Primary Outcome Measures

Name	Time	Method
Body Mass Index	Assess change from baseline to 3-month follow-up and 1-year follow-up.	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.

Secondary Outcome Measures

Name	Time	Method
Eating Disorder Diagnostic Scale	Assess change from baseline to 3-month follow-up and 1-year follow-up.	The Eating Disorder Diagnostic Interview is a 23-item questionnaire used to assess assesses symptoms of anorexia nervosa, bulimia nervosa, and binge eating disorder, which will allow us to exclude participants with these disorders. It also provides a continuous measure of overall eating disorder symptoms.
Positive and Negative Affect Schedule	Assess change from baseline to 3-month follow-up and 1-year follow-up.	The Positive and Negative Affect Schedule will assess the extent that participants experience 20 different feelings and emotions (e.g., distressed, excited) on a 5-point Likert-type scale ranging from 1 (very slightly or not at all) to 5 (extremely). The PANAS subscale negative affectivity will be summed (possible range = 41 - 205) and lower scores indicating better outcomes.
Food Craving Inventory	Assess change from baseline to 3-month follow-up and 1-year follow-up.	The Food Craving Inventory is a 28-item self-report instrument that is widely used to measure overall food cravings as well as craving for sweet food, high-fat food, starchy food, and fast-food (FCI-FF). Items are rated on a scale from 1 (Never) to 5 (Always/Almost every day) and averaged with lower scores indicating better outcomes (possible range = 1-5).

Trial Locations

Locations (1)

RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity; 🇺🇸 Houston, Texas, United States