A Peer and Family-Based Approach to Obesity in African American Families
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Weight loss of parents
研究概览
简要总结
This study tests the effectiveness of parent and family oriented support interventions that are designed to help with weight loss among African American families. Obesity tends to run in families, thus family based interventions, with parents as main change agents have been strongly recommended. The parent and family oriented support Interventions may help facilitate weight loss among African American families.
详细描述
PRIMARY OBJECTIVES:
I. Determine whether a parent/caregiver intervention or a family intervention can produce greater weight loss among obese African American (AA) parents at 12 months compared to a cancer prevention group (control).
II. Use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) model, to evaluate individual and church-level barriers and facilitators on program reach, effectiveness, adoption, implementation, maintenance and dissemination.
SECONDARY OBJECTIVES:
I. Explore whether a parent/caregiver intervention and a family intervention can produce weight maintenance or weight loss, as determined by change in body mass index (BMI) z-score, among AA children at risk for obesity at 12 months compared to the control group.
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 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DYAD: Be parent/caregiver (legal parent or custodial grandparent; male or female) and child willing to participate
- •DYAD: Live together in the same household
- •PARENT/CAREGIVER: Self-identify as a racial ethic minority (i.e., black or African American or Hispanic)
- •PARENT/CAREGIVER: Parent or caregiver age 18 through 65 years old
- •PARENT/CAREGIVER: Are overweight (BMI greater than or equal to 25);
- •PARENT/CAREGIVER: Are not currently participating in a physical activity (PA), diet, or weight management program
- •PARENT/CAREGIVER: Have a valid home address, telephone number, and internet access
- •PARENT/CAREGIVER: Enroll with a child aged 8-17 years
- •PARENT/CAREGIVER: Are able to speak English
排除标准
- •PARENT/CAREGIVER: They are currently pregnant or thinking about becoming pregnant during the study period
- •PARENT/CAREGIVER: They present any contraindications for exercise based on responses to the PA Readiness Questionnaire plus (PAR-Q +)
- •Exclusion criteria for child:
研究组 & 干预措施
Group III (educational handbook)
Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention.
干预措施: Informational Intervention (Other)
Group I (coaching session, navigation session, support group)
Parents/caregivers whose churches are randomized to Group I, attend monthly health coaching sessions over 1 hour each for 12 months, 9 resource navigation sessions over 12 months, and monthly support groups for 12 months.
干预措施: Educational Activity (Other)
Group I (coaching session, navigation session, support group)
Parents/caregivers whose churches are randomized to Group I, attend monthly health coaching sessions over 1 hour each for 12 months, 9 resource navigation sessions over 12 months, and monthly support groups for 12 months.
干预措施: Educational Intervention (Other)
Group I (coaching session, navigation session, support group)
Parents/caregivers whose churches are randomized to Group I, attend monthly health coaching sessions over 1 hour each for 12 months, 9 resource navigation sessions over 12 months, and monthly support groups for 12 months.
干预措施: Questionnaire Administration (Other)
Group I (coaching session, navigation session, support group)
Parents/caregivers whose churches are randomized to Group I, attend monthly health coaching sessions over 1 hour each for 12 months, 9 resource navigation sessions over 12 months, and monthly support groups for 12 months.
干预措施: Support Group Therapy (Procedure)
Group II (coaching session, navigation session, support group)
Families whose churches are randomized to Group II, attend monthly health coaching sessions over 1 hour each for 12 months, 9 resource navigation sessions over 12 months, and monthly support groups for 12 months.
干预措施: Educational Activity (Other)
Group II (coaching session, navigation session, support group)
Families whose churches are randomized to Group II, attend monthly health coaching sessions over 1 hour each for 12 months, 9 resource navigation sessions over 12 months, and monthly support groups for 12 months.
干预措施: Educational Intervention (Other)
Group II (coaching session, navigation session, support group)
Families whose churches are randomized to Group II, attend monthly health coaching sessions over 1 hour each for 12 months, 9 resource navigation sessions over 12 months, and monthly support groups for 12 months.
干预措施: Questionnaire Administration (Other)
Group II (coaching session, navigation session, support group)
Families whose churches are randomized to Group II, attend monthly health coaching sessions over 1 hour each for 12 months, 9 resource navigation sessions over 12 months, and monthly support groups for 12 months.
干预措施: Support Group Therapy (Procedure)
Group III (educational handbook)
Families whose churches are randomized to Group III, receive an educational handbook on cancer prevention.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Weight loss of parents
时间窗: Up to 18 months
Will use the generalized linear mixed model (GLMM) regression, which takes into account both within-cluster (e.g., within church) and, as applicable, within-individual (e.g., overtime) correlations between observations of each primary and secondary outcomes of interest.
Adoption (Part 3 of the RE-AIM framework)
时间窗: Up to 18 months
Will be measured by asking churches about factors that helped or hindered adoption or implementation and will they adopt intervention when completed.
Maintenance (Part 5 of the RE-AIM framework)
时间窗: Up to 18 months
Long-term maintenance in parent/families at 18 months measured by family and church attrition, to assess church's ability to maintain employment of LHWs and their willingness to remain in this role.
Effectiveness (Part 2 of the RE-AIM framework)
时间窗: Up to 18 months
Measured as the impact on weight loss: 6 focus groups and 15 individual interviews at 18 months to understand unanticipated outcomes; interview lay health workers (LHWs) about implementation.
Implementation (Part 4 of the RE-AIM framework)
时间窗: Up to 18 months
Measured as study attendance and assessments, number of health coaching, LHW and support group sessions, number of staff training, and self-monitoring practices.
Reach (Part 1 of the RE-AIM framework)
时间窗: Up to 18 months
Measured as the number of churches invited to participate, number enrolled, and differences between the two groups.
次要结局
- Waist circumference(Up to 18 months)
- Child's body mass index (BMI) z-score(Up to 18 months)
- Blood pressure(Up to 18 months)
- Body fat percentage(Up to 18 months)
- Physical activity(Up to 18 months)
- Fruit and vegetable consumption(Up to 18 months)