Obesity
Conditions
Keywords
Obesity, Eating, Physical Activity, Exercise
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.
Interventions
BEHAVIORALProject Health
This intervention involves a one-hour group meeting for six consecutive weeks.
This intervention involves a one-hour educational video control viewing for six consecutive weeks.
Sponsors
University of Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eating Disorder Diagnostic Scale | 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. |
| Positive and Negative Affect Schedule | 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. |
| Food Craving Inventory | 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). |
Countries
United States
Contacts
Primary ContactPamella Nizio, B.S.
Backup ContactBrooke Kauffman, Ph.D.
Outcome results
None listed