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Project Health Intervention Among Latinx Adults in Primary Care

NCT ID: NCT04090515

Last Updated: 2021-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-03

Study Completion Date

2022-12-31

Brief Summary

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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

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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.

Conditions

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Obesity

Keywords

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Obesity Eating Physical Activity Exercise

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Project Health

Intervention Type BEHAVIORAL

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

Educational Video Control

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

Group Type PLACEBO_COMPARATOR

Educational Video Control

Intervention Type OTHER

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

Interventions

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Project Health

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

Intervention Type BEHAVIORAL

Educational Video Control

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Houston

OTHER

Sponsor Role lead

Responsible Party

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Michael J. Zvolensky, Ph.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael J Zvolensky, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Houston

Locations

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

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pamella Nizio, B.S.

Role: CONTACT

Phone: (713) 743-8056

Email: [email protected]

Brooke Kauffman, Ph.D.

Role: CONTACT

Email: [email protected]

Facility Contacts

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Pamella Nizio, B.S.

Role: primary

Other Identifiers

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STUDY00001757

Identifier Type: -

Identifier Source: org_study_id