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Project Health Intervention Among Latinx Adults in Primary Care

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ClinicalTrials.gov Identifier: NCT04090515
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Michael J. Zvolensky, Ph.D., University of Houston

Brief Summary:
The proposed study will examine acceptability/feasibility of an existing intervention (Project Health) on a sample of 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Project Health Other: Educational Video Control Not Applicable

Detailed Description:
The primary goal of the research study is to investigate the acceptability/feasibility of Project Health that addresses dietary intake and exercise to reduce eating disorder symptoms, BMI, body dissatisfaction, negative affect, dietary intake, emotional eating, substance use, sociocultural pressures to be thin, food cravings, and impulsivity at post-intervention and increase levels of cognitive dissonance about engaging in behaviors that produce obesity and a sedentary lifestyle. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: If participant meets eligibility criteria, the participant will be randomly assigned to one of two conditions: either (1) active or (2) educational video control
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Project Health Intervention Among Latinx Adults in Primary Care
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Body Mass Index [ Time Frame: Assess change from baseline to 3-month 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.

  2. Eating Disorder Diagnostic Interview [ Time Frame: Assess change from baseline to 3-month follow-up. ]
    The Eating Disorder Diagnostic Interview is a 31-item questionnaire used to assess DSM-IV eating disorder symptoms. Items assessing symptoms in the past month at each assessment will be summed to form a composite score with lower scores indicating better outcomes.

  3. Body Esteem Scale [ Time Frame: Assess change from baseline to 3-month follow-up. ]
    The 35-item Body Esteem Scale assesses opinions about body parts and functions. Items are rated on a five-point Likert scale ranging from 1 (Have strong negative feelings) to 5 (Have strong positive feelings). The measure yields three subscales for female respondents [Sexual Attractiveness (possible range = 13 - 65), Weight Concern (possible range = 10 - 50), Physical Condition (possible range = 9 - 45)] and male respondents [Physical Attractiveness (possible range = 11-55), Upper Body Strength (possible range = 9 - 45), Physical Condition (possible range = 13 - 65)]. Scores for each subscale are obtained by summing responses to all items comprising each subscale with higher scores indicating better outcomes.

  4. Positive and Negative Affect Schedule [ Time Frame: Assess change from baseline to 3-month 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.

  5. Food Habits Questionnaire [ Time Frame: Assess change from baseline to 3-month follow-up. ]
    The Food Habits Questionnaire is a 49-item, self-report measure of overall dietary quality. Items are rated on a Likert-type scale from 0 (I don't use this food) to 4 (Usually or Always: 3 to 7 times/week). The measure consists of 6 subscales: Grains, Vegetables and Fruits, Dairy Products, Meat and Poultry, Other Foods, and Fats and Oils. For the current study, the Food Habits Questionnaire total score (all items summed) will be used as a measure of overall dietary quality (possible range = 23 - 219) with higher scores indicating better outcomes.

  6. Dutch Eating Behavior Questionnaire [ Time Frame: Assess change from baseline to 3-month follow-up. ]
    The Dutch Eating Behavior Questionnaire will be used to assess emotional eating. Items are rated on a 5-point Likert scale ranging from 1 (never) to 5 (very often). For the current study, the emotional eating subscale (13 items) will be used as a measure of emotional eating. The 13 items of the subscale are summed and divided by 13 to create a mean score with a range from 1-5. Lower scores on this measure indicate better outcomes.

  7. Substance Use Scale [ Time Frame: Assess change from baseline to 3-month follow-up. ]
    The Substance Use Scale is a 10-item measures that assesses the frequency of use of various substances during the past year. Items used six-point response scales ranging from never to 5-7 times a week for frequency of use, zero to six or more drinks for quantity of alcohol use, and zero to 21 or more cigarettes a day for frequency of cigarette use. Items are averaged to form an overall substance use measure with lower scores indicating better outcomes (possible range 0 - 6).

  8. Perceived Sociocultural Pressure Scale [ Time Frame: Assess change from baseline to 3-month follow-up. ]
    The Perceived Sociocultural Pressure Scale assesses how much pressure participants feel from their family and friends to be thin. For the current study, an expanded, 20-item version of the scale will be used. Because this sample may include males, we will add 8 items assessing perceived pressure for muscularity, as well as 4 items that assess appearance criticism. Items are rated on a Likert-type scale ranging from 1 (None) to 5 (A lot). Responses are averaged to form a scale score (possible range =1= 5) with lower scores indicating better outcomes.

  9. Food Craving Inventory [ Time Frame: Assess change from baseline to 3-month 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).

  10. Impulsivity [ Time Frame: Assess change from baseline to 3-month follow-up. ]
    The 30-item Barratt Impulsivity Scale assesses impulsivity. Items are measured on a 4-point Likert scale (1 = rarely/never to 4 = almost always/always). The total score be calculated by summing item responses, with scores ranging from 30-120 with lower scores indicating better outcomes.

  11. Cognitive Dissonance [ Time Frame: Assess change from baseline to 3-month follow-up. ]
    Cognitive Dissonance : The 14-Item Dissonance Regarding Unhealthy Lifestyle Behaviors Scale assesses cognitive dissonance. Items are rated on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). Items will be averaged to form a mean total score (possible range = 1 - 5), with higher scores indicating better outcomes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 DSM-V anorexia nervosa, bulimia nervosa, or binge eating disorder
  • Suicidality.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090515


Contacts
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Contact: Pamella Nizio, B.S. (713) 743-8056 niziopam@gmail.com
Contact: Brooke Kauffman, M.A. niziopam@gmail.com bkauffma@central.uh.edu

Locations
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United States, Texas
Anxiety and Health Research Laboratory and Substance Use Treatment Clinic, University of Houston Not yet recruiting
Houston, Texas, United States, 77204
Contact: Pamella Nizio, B.S.    713-743-8056    niziopam@gmail.com   
Principal Investigator: Michael J Zvolensky, Ph.D.         
Sponsors and Collaborators
University of Houston
Investigators
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Principal Investigator: Michael J Zvolensky, Ph.D. University of Houston

Additional Information:
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Responsible Party: Michael J. Zvolensky, Ph.D., Principal Investigator, University of Houston
ClinicalTrials.gov Identifier: NCT04090515     History of Changes
Other Study ID Numbers: STUDY00001757
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael J. Zvolensky, Ph.D., University of Houston:
Obesity
Eating
Physical Activity
Exercise
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms