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临床试验/NCT02458053
NCT02458053已完成不适用

Testing the Efficacy of a Spousal Support Enhanced Weight Loss Program on Weight Loss Among African American Men

University of North Carolina, Chapel Hill2 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2016年2月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
104
试验地点
2
主要终点
Weight

研究概览

简要总结

The purpose of this study is to determine the effect of a spousal support enhanced weight loss program on weight loss among African American men.

详细描述

In 2012, African Americans (AA) were 1.4 times more likely to be overweight and obese than non-Hispanic Whites. The Office of Minority Health reports the prevalence of overweight and obesity (BMI>25) among AA men age 20 and older is 70%. AA men suffer disproportionately from obesity-related consequences. Modest weight loss (WL) of 10% or less improves cardiovascular disease risk factors and reduces the risk of type 2 diabetes. However, the majority of participants in lifestyle weight loss (LWL) interventions are most commonly Caucasian women. While men are unrepresented in weight loss programs; even fewer studies examine WL in AA men. Only 4.5% of AA men participate in research studies, according to the National Institute of Health (NIH). When AA men have participated in LWL interventions, they have loss less weight compared to Caucasian men. Consequently, the evidence on the appropriateness of the current WL strategies and recommendations for AA men is limited.

There is limited literature on the appropriate strategies for WL in AA men because of their lack of participation. Social support is a predictor of weight loss and support from family is important in AA culture. Spousal support results, defined as spouse or significant other, are inconsistent and are largely conducted in Caucasian populations. The use of individual based theoretical frameworks may explain these inconsistencies. Using a dyad based framework like the Interdependence Theory may produce different results. The use of a dyad based theoretical framework and testing the effects of spousal support adds to the literature of WL among AA men.

This study seeks to determine the best strategies to attract overweight and obese AA men to participate and examine the efficacy of a 3 month spousal support enhanced behavioral weight loss intervention focused on behavior modification, nutrition and physical activity compared to a traditional intervention in achieving clinical significant weight loss in AA men. Using 2 arms randomized controlled trial (RCT) 26 AA men and their partners will be recruited to participate in each arm in Orange, Durham and Wake County, North Carolina. The investigator hypothesizes the proposed TEAM (Together Eating & Activity Matters) program, a spousal support enhanced WL intervention, will result in clinical weight loss among AA men.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • The participant self-identifies as African American male.
  • The participant is between the ages of 18 and
  • The participant has a BMI between 25 and 45 kg/m
  • The participant enrolls with an African American overweight female spouse or cohabiting intimate partner
  • The participant has weekly access to the internet and/or a mobile phone with internet capabilities.

排除标准

  • Both the participant and the partner are not willing and interested in losing weight.
  • The participant is taking any medications that affect weight.
  • The participant is participating in any other weight loss program.
  • The participant has recently lost 10 lbs or more.
  • The participant is expecting to relocate within the next 6 months.

研究组 & 干预措施

TEAM Enhanced

Experimental

The enhanced intervention will include group sessions where the participant attends with partner ( including a couples skill training session), weekly tailored feedback, and weekly lessons.

干预措施: Feedback (Behavioral)

TEAM Enhanced

Experimental

The enhanced intervention will include group sessions where the participant attends with partner ( including a couples skill training session), weekly tailored feedback, and weekly lessons.

干预措施: Attends with partner (Behavioral)

TEAM Enhanced

Experimental

The enhanced intervention will include group sessions where the participant attends with partner ( including a couples skill training session), weekly tailored feedback, and weekly lessons.

干预措施: Couples Skill Training (Behavioral)

TEAM Enhanced

Experimental

The enhanced intervention will include group sessions where the participant attends with partner ( including a couples skill training session), weekly tailored feedback, and weekly lessons.

干预措施: Face to face group sessions (Behavioral)

TEAM Enhanced

Experimental

The enhanced intervention will include group sessions where the participant attends with partner ( including a couples skill training session), weekly tailored feedback, and weekly lessons.

干预措施: Self Monitor (Behavioral)

TEAM Enhanced

Experimental

The enhanced intervention will include group sessions where the participant attends with partner ( including a couples skill training session), weekly tailored feedback, and weekly lessons.

干预措施: Notebook (Other)

TEAM Traditional

Active Comparator

The intervention will include group sessions where the male attends alone, weekly tailored feedback, and weekly lessons.

干预措施: Face to face group sessions (Behavioral)

TEAM Traditional

Active Comparator

The intervention will include group sessions where the male attends alone, weekly tailored feedback, and weekly lessons.

干预措施: Self Monitor (Behavioral)

TEAM Traditional

Active Comparator

The intervention will include group sessions where the male attends alone, weekly tailored feedback, and weekly lessons.

干预措施: Notebook (Other)

TEAM Traditional

Active Comparator

The intervention will include group sessions where the male attends alone, weekly tailored feedback, and weekly lessons.

干预措施: Feedback (Behavioral)

结局指标

主要结局

Weight

时间窗: Baseline, 6 weeks, 12 weeks

Body weight(kg) expressed as a continuous variable will be collected on a digital scale.

次要结局

  • Social Support(Baseline, 6 weeks, 12 weeks)
  • Couple/Family Variables(Baseline, 12 weeks)
  • BMI(Baseline,12 weeks)
  • Behavior(Baseline, 12 weeks)
  • Blood pressure(Baseline, 12 weeks)
  • Waist Circumference(Baseline,12 weeks)
  • Psychosocial variables(Baseline, 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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