Project Health Intervention Among Latinx Adults in Primary Care

November 23, 2021 updated by: Michael J. Zvolensky, Ph.D., University of Houston
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77204
        • Recruiting
        • RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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.
Behavioral: Project Health
This intervention involves a one-hour group meeting for six consecutive weeks.
PLACEBO_COMPARATOR: Educational Video Control
The educational video control condition will include an educational video series on obesity in Spanish.
Other: Educational Video Control
This intervention involves a one-hour educational video control viewing for six consecutive weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body Mass Index
Time Frame: Assess change from baseline to 3-month follow-up and 1-year follow-up.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Eating Disorder Diagnostic Scale
Time Frame: Assess change from baseline to 3-month follow-up and 1-year follow-up.
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.
Positive and Negative Affect Schedule
Time Frame: Assess change from baseline to 3-month follow-up and 1-year follow-up.
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.
Food Craving Inventory
Time Frame: Assess change from baseline to 3-month follow-up and 1-year follow-up.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 12, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00001757

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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