Project Health Intervention Among Latinx Adults in Primary Care

University of Houston

Status: Unknown

Conditions: Obesity

Treatments: Other: Educational Video Control; Behavioral: Project Health

Study type: Interventional

Funder types: Other

Identifiers

NCT04090515

STUDY00001757

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups, including a placebo group

Project Health

Experimental group

Description:

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.

Treatment:

Behavioral: Project Health

Educational Video Control

Placebo Comparator group

Description:

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

Treatment:

Other: Educational Video Control