Project Health Intervention Among Latinx Adults in Primary Care
试验速览
- 阶段
- 不适用
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Body Mass Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Body Mass Index
时间窗: 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.
次要结局
- Eating Disorder Diagnostic Scale(Assess change from baseline to 3-month follow-up and 1-year follow-up.)
- Positive and Negative Affect Schedule(Assess change from baseline to 3-month follow-up and 1-year follow-up.)
- Food Craving Inventory(Assess change from baseline to 3-month follow-up and 1-year follow-up.)
研究者
Michael J. Zvolensky, Ph.D.
Principal Investigator
University of Houston