Clinical trial NCT04090515: Project Health Intervention Among Latinx Adults in Primary Care
Official title: Project Health Intervention Among Latinx Adults in Primary Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Obesity
Eating
Physical Activity
Exercise
Lead sponsor: University of Houston
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Body Mass Index
timeFrame: Assess change from baseline to 3-month follow-up and 1-year follow-up.
Secondary outcomes:
measure: Eating Disorder Diagnostic Scale
timeFrame: Assess change from baseline to 3-month follow-up and 1-year follow-up.
measure: Positive and Negative Affect Schedule
timeFrame: Assess change from baseline to 3-month follow-up and 1-year follow-up.
measure: Food Craving Inventory
timeFrame: Assess change from baseline to 3-month follow-up and 1-year follow-up.
Other outcomes:
Locations:
city: Houston
country: United States
facility: RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
state: Texas
Study officials:
affiliation: University of Houston
name: Michael J Zvolensky, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: