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临床试验/NCT05094466
NCT05094466进行中(未招募)不适用

A Family-Based Approach to Reducing Obesity Risk Among African American Families

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年7月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120
试验地点
1
主要终点
The correlation between the acceptability of the Parent and Family obesity interventions.

研究概览

简要总结

This clinical trial compares the effects of parent/caregiver-focused programs to family-focused programs in reducing obesity risk in racial ethnic minority families. Obesity tends to run in families, thus family-based interventions have been strongly recommended. Parent and family obesity programs may reduce obesity risk and ultimately reduce the risk of obesity-related cancer.

详细描述

PRIMARY OBJECTIVE:

I. Establish the feasibility and acceptability of the Parent and Family obesity interventions.

SECONDARY OBJECTIVES:

I. Explore congregational and community interest in obesity and obesity related behaviors in racial ethnic minorities.

II. Explore the preliminary impact of the Parent and Family interventions on behavioral, social and environmental outcomes in parent/child dyads. III. Explore potential mediators (self-efficacy, perceived stress, depressive symptoms) and moderators (sex of dyads, family history of lifestyle changes, and church attendance).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ELIGIBLE IN-DEPTH INTERVIEW PARTICIPANTS: Any church leader, such as pastors, minister, church secretary, health ministry leader, youth leader, deacons, ministry leader, director
  • PARENT-CHILD DYADS: Be parent/caregiver (legal parent or custodial grandparent; male or female) and child willing to participate
  • PARENT-CHILD DYADS: Live together in the same household
  • PARENTS/CAREGIVERS: Self-identify as a racial ethnic minority (i.e., black or African American or Hispanic)
  • PARENTS/CAREGIVERS: Parent or caregiver age 18 through 65 years old
  • PARENTS/CAREGIVERS: Are obese (body mass index [BMI] >= 30)
  • PARENTS/CAREGIVERS: Are not currently participating in a physical activity (PA), diet, or weight management program
  • PARENTS/CAREGIVERS: Enroll with a child aged 10-16 years
  • PARENTS/CAREGIVERS: Have a valid home address, telephone number, and internet access
  • PARENTS/CAREGIVERS: Are able to speak, read, and write in English
  • CHILDREN: They are aged between 10-16 years

排除标准

  • PARENTS/CAREGIVERS: They are currently pregnant or thinking about becoming pregnant during study period
  • PARENTS/CAREGIVERS: They present any contraindications for exercise based on responses to the PA Readiness Questionnaire
  • PARENTS/CAREGIVERS: Principal investigator (PI) determines that parent/caregiver is unsuitable for the study for reasons not otherwise stated in the protocol

研究组 & 干预措施

Arm III (delayed comparison)

Active Comparator

Participants receive a handbook that includes core content from the parent and family interventions, but without individual support from coaches, LHWs or the church.

干预措施: Discussion (Procedure)

Arm III (delayed comparison)

Active Comparator

Participants receive a handbook that includes core content from the parent and family interventions, but without individual support from coaches, LHWs or the church.

干预措施: Educational Intervention (Other)

Arm III (delayed comparison)

Active Comparator

Participants receive a handbook that includes core content from the parent and family interventions, but without individual support from coaches, LHWs or the church.

干预措施: Interview (Other)

Arm I (parent intervention)

Experimental

Parents receive health coaching sessions over 50-60 minutes monthly for 6 months. Parents also receive navigation sessions with a lay LHW monthly for 6 months and church-based peer support monthly for 6 months.

干预措施: Behavioral Intervention (Behavioral)

Arm I (parent intervention)

Experimental

Parents receive health coaching sessions over 50-60 minutes monthly for 6 months. Parents also receive navigation sessions with a lay LHW monthly for 6 months and church-based peer support monthly for 6 months.

干预措施: Counseling (Other)

Arm I (parent intervention)

Experimental

Parents receive health coaching sessions over 50-60 minutes monthly for 6 months. Parents also receive navigation sessions with a lay LHW monthly for 6 months and church-based peer support monthly for 6 months.

干预措施: Discussion (Procedure)

Arm I (parent intervention)

Experimental

Parents receive health coaching sessions over 50-60 minutes monthly for 6 months. Parents also receive navigation sessions with a lay LHW monthly for 6 months and church-based peer support monthly for 6 months.

干预措施: Educational Intervention (Other)

Arm I (parent intervention)

Experimental

Parents receive health coaching sessions over 50-60 minutes monthly for 6 months. Parents also receive navigation sessions with a lay LHW monthly for 6 months and church-based peer support monthly for 6 months.

干预措施: Informational Intervention (Other)

Arm I (parent intervention)

Experimental

Parents receive health coaching sessions over 50-60 minutes monthly for 6 months. Parents also receive navigation sessions with a lay LHW monthly for 6 months and church-based peer support monthly for 6 months.

干预措施: Interview (Other)

Arm II (family intervention)

Experimental

Family members receive health coaching sessions over 50-60 minutes monthly for 6 months. Family members also receive navigation sessions with a LHW monthly for 6 months and church-based peer support monthly for 6 months.

干预措施: Discussion (Procedure)

Arm II (family intervention)

Experimental

Family members receive health coaching sessions over 50-60 minutes monthly for 6 months. Family members also receive navigation sessions with a LHW monthly for 6 months and church-based peer support monthly for 6 months.

干预措施: Behavioral Intervention (Behavioral)

Arm II (family intervention)

Experimental

Family members receive health coaching sessions over 50-60 minutes monthly for 6 months. Family members also receive navigation sessions with a LHW monthly for 6 months and church-based peer support monthly for 6 months.

干预措施: Counseling (Other)

Arm II (family intervention)

Experimental

Family members receive health coaching sessions over 50-60 minutes monthly for 6 months. Family members also receive navigation sessions with a LHW monthly for 6 months and church-based peer support monthly for 6 months.

干预措施: Educational Intervention (Other)

Arm II (family intervention)

Experimental

Family members receive health coaching sessions over 50-60 minutes monthly for 6 months. Family members also receive navigation sessions with a LHW monthly for 6 months and church-based peer support monthly for 6 months.

干预措施: Informational Intervention (Other)

Arm II (family intervention)

Experimental

Family members receive health coaching sessions over 50-60 minutes monthly for 6 months. Family members also receive navigation sessions with a LHW monthly for 6 months and church-based peer support monthly for 6 months.

干预措施: Interview (Other)

结局指标

主要结局

The correlation between the acceptability of the Parent and Family obesity interventions.

时间窗: Up to 4 years

The correlation between the feasibility of the Parent and Family obesity interventions.

时间窗: Up to 4 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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