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Project Health Intervention Among Latinx Adults in Primary Care

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project Health
Educational Video Control
Sponsored by
University of Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Eating, Physical Activity, Exercise

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Project Health

Educational Video Control

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).

Full Information

First Posted
September 12, 2019
Last Updated
November 23, 2021
Sponsor
University of Houston
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1. Study Identification

Unique Protocol Identification Number
NCT04090515
Brief Title
Project Health Intervention Among Latinx Adults in Primary Care
Official Title
Project Health Intervention Among Latinx Adults in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Eating, Physical Activity, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Masking
Participant
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Project Health
Arm Type
Experimental
Arm 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.
Arm Title
Educational Video Control
Arm Type
Placebo Comparator
Arm Description
The educational video control condition will include an educational video series on obesity in Spanish.
Intervention Type
Behavioral
Intervention Name(s)
Project Health
Intervention Description
This intervention involves a one-hour group meeting for six consecutive weeks.
Intervention Type
Other
Intervention Name(s)
Educational Video Control
Intervention Description
This intervention involves a one-hour educational video control viewing for six consecutive weeks.
Primary Outcome Measure Information:
Title
Body Mass Index
Description
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.
Time Frame
Assess change from baseline to 3-month follow-up and 1-year follow-up.
Secondary Outcome Measure Information:
Title
Eating Disorder Diagnostic Scale
Description
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.
Time Frame
Assess change from baseline to 3-month follow-up and 1-year follow-up.
Title
Positive and Negative Affect Schedule
Description
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.
Time Frame
Assess change from baseline to 3-month follow-up and 1-year follow-up.
Title
Food Craving Inventory
Description
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).
Time Frame
Assess change from baseline to 3-month follow-up and 1-year follow-up.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamella Nizio, B.S.
Phone
(713) 743-8056
Email
niziopam@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Brooke Kauffman, Ph.D.
Email
bkauffma@central.uh.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Zvolensky, Ph.D.
Organizational Affiliation
University of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamella Nizio, B.S.
Phone
713-743-8056
Email
niziopam@gmail.com
First Name & Middle Initial & Last Name & Degree
Michael J Zvolensky, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Project Health Intervention Among Latinx Adults in Primary Care

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