Project Health Intervention Among Latinx Adults in Primary Care

Obesity Clinical Trial

Official title:

Project Health Intervention Among Latinx Adults in Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04090515
• Other study ID #: STUDY00001757
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2021
• Source: University of Houston
• Contact: Pamella Nizio, B.S.
• Phone: (713) 743-8056
• Email: niziopam[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Project Health
This intervention involves a one-hour group meeting for six consecutive weeks.

Other:
• Educational Video Control
This intervention involves a one-hour educational video control viewing for six consecutive weeks.

Locations

Country	Name	City	State
United States	RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Eating Disorder Diagnostic Scale	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.	Assess change from baseline to 3-month follow-up and 1-year follow-up.
Secondary	Positive and Negative Affect Schedule	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.	Assess change from baseline to 3-month follow-up and 1-year follow-up.
Secondary	Food Craving Inventory	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).	Assess change from baseline to 3-month follow-up and 1-year follow-up.

External Links

•   Project Website