ObesityNCT04090515
Project Health Intervention Among Latinx Adults in Primary Care
A study testing Project Health in people with Obesity, run by University of Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Project Health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brooke Kauffman, Ph.D. contact
United States1 site, 1 recruiting
- Recruiting
RESTORE Laboratory: Research on Emotion, Substance Treatment Outcomes, and Racial Equity
Houston, Texas, 77204
Pamella Nizio, B.S., 713-743-8056, niziopam@gmail.com
Michael J Zvolensky, Ph.D.
About this study
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Project Health, Educational Video Control
- Keywords
- Obesity, Eating, Physical Activity, Exercise
- Medical subject headings
- Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project HealthBehavioural
This intervention involves a one-hour group meeting for six consecutive weeks.
Educational Video ControlOther
This intervention involves a one-hour educational video control viewing for six consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Project Health | Experimental | 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. Receives: Behavioral: Project Health |
| Educational Video Control | Placebo comparator | The educational video control condition will include an educational video series on obesity in Spanish. Receives: Other: Educational Video Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assess change from baseline to 3-month follow-up and 1-year follow-up.
Secondary outcomes (3)
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.
Measured: Assess change from baseline to 3-month follow-up and 1-year follow-up.
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.
Measured: Assess change from baseline to 3-month follow-up and 1-year follow-up.
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).
Measured: Assess change from baseline to 3-month follow-up and 1-year follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start3 Nov 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Zvolensky, Ph.D., University of Houston
- Investigators
- Michael J Zvolensky, Ph.D., Principal investigator, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090515
- Sponsor's protocol ID
- STUDY00001757
- Status last verified
- Nov 2021
- First submitted
- 12 Sep 2019
- Last updated
- 30 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Health Intervention Among Latinx Adults in Primary Care
- ClinicalTrials.gov ID
- NCT04090515
- Acronym / sponsor ID
- STUDY00001757
- Conditions
- Obesity
- Keywords
- Obesity, Eating, Physical Activity, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Project Health | Experimental | Behavioral: Project HealthProject 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. |
| Educational Video Control | Placebo comparator | Other: Educational Video ControlThe educational video control condition will include an educational video series on obesity in Spanish. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project HealthThis intervention involves a one-hour group meeting for six consecutive weeks. | Behavioural | Project Health |
| Educational Video ControlThis intervention involves a one-hour educational video control viewing for six consecutive weeks. | Other | Educational Video Control |
Primary outcome
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.
3 secondary outcomes
Eating Disorder Diagnostic Scale
Time frame: 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.
Food Craving Inventory
Time frame: Assess change from baseline to 3-month follow-up and 1-year follow-up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brooke Kauffman, Ph.D. contact
Michael J Zvolensky, Ph.D. principal investigator
University of Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Health in people with Obesity, run by University of Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pamella Nizio, B.S. ((713) 743-8056, niziopam@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Mass Index (time frame: Assess change from baseline to 3-month follow-up and 1-year follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2021.