Family Diabetes Prevention Program Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Recruitment Rate as Assessed by the Rate of Enrollment Per Week
研究概览
简要总结
This study will examine the feasibility and acceptability of a family-oriented augmentation of the Diabetes Prevention Program lifestyle intervention (DPP), called the Family DPP. It will also preliminarily examine adult and child health and health behavior outcomes. The DPP is a 12-month, group-based lifestyle intervention for adults at high-risk for type 2 diabetes, in which adult participants learn skills and strategies to achieve the program's goals of 5% weight loss and 150 minutes/week of moderate-vigorous physical activity. The Family DPP will consist of all elements of the evidence-based DPP, along with augmentations including additional child-focused sessions in which adult participants will learn about principles and strategies for promoting healthy lifestyle behaviors in children, ages 5 through 12 years. Children may participate in certain child-focused sessions, too. The non-randomized pilot feasibility study will consists of 2 arms/groups: 1) the concurrent "control" group, consisting of adults who are enrolled in the DPP; and 2) the "intervention" arm, in which the adult participants will engage in the Family DPP (and children may participate in certain aspects of the Family DPP focused on children). The study will recruit 10-15 adult-child dyads, for the "intervention" groups, and 10-15 adults for the concurrent control group. In addition to data collected from adult participants as a routine part of the DPP, the study will examine additional adult health behaviors and health outcomes and child health outcomes (change in body mass index z-score) and health behaviors at baseline, 6 months and 12 months (program end) among participants in the "intervention" group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for the Intervention Arm:
- •For ADULT participants, inclusion criteria are:
- •Meeting eligibility criteria for the CDC's National Diabetes Prevention Program lifestyle intervention, which are:
- •18 years of age and older;
- •not pregnant at time of enrollment;
- •body mass index (BMI) of ≥25 kg/m2 (≥23 kg/m2 , if of Asian race);
- •meet one of the following: a) have prediabetes (defined as fasting glucose of 100-125 mg/dL; plasma glucose measured 2 hours after 75 gm glucose load of 140 to 199 mg/dL, or A1c of 5.7% to 6.4%); b) history of clinically diagnosed gestational diabetes mellitus (GDM) during a previous pregnancy; c) high risk for diabetes based on CDC or American Diabetes Association (ADA) Diabetes Screening Test).
- •being a primary caregiver of at least one eligible child aged 5 through 12 years at time of recruitment (defined as caring for the child, with a responsibility for the child's food, sleep and activity habits, at least 3 days out of the week)
- •For CHILD participants, inclusion criteria are:
- •being aged 5 through 12 years at time of recruitment;
- •not having a medical condition which leads to inability to comply with general pediatric dietary or physical activity goals; AND
- •not concurrently enrolled in a structured weight management program.
排除标准
- •for Intervention Arm:
- •For ADULT participants, exclusion criteria include
- •Conditions that would exclude their participation in the DPP lifestyle intervention which include:
- •having end-stage renal disease;
- •having type 1 or type 2 diabetes.
- •They will also be excluded if they are concurrently enrolled in a structured weight management program.
- •For CHILD participants: exclusion criteria include:
- •having a medical condition which leads to inability to comply with general pediatric dietary or physical activity goals;
- •being enrolled in a structured weight management program.
- •For the Control Arm/Concurrent Control Group, this will only enroll ADULT participants.
- •The inclusion criteria are:
- •Being a participant in the Brancati Center's Diabetes Prevention Program, in a group that has started within 6 months of Intervention Arm group start
- •Lives with a child less than 18 years of age in their household
研究组 & 干预措施
Diabetes Prevention Program (DPP)
Adult participants who are engaged in the Centers for Disease Control and Prevention's (CDC) National Diabetes Prevention Program lifestyle intervention (DPP) as delivered by the Johns Hopkins Brancati Center; this is a 12-month long, group-based lifestyle intervention, delivered by a certified lifestyle coach using a CDC-approved curriculum. This "concurrent control" group will consist of adults who are enrolled in the Brancati Center's DPP within 6 months of the intervention group start dates, who have children less than 18 years of age living in their households.
干预措施: National Diabetes Prevention Program Lifestyle Intervention (DPP) (Behavioral)
Family Diabetes Prevention Program (Family DPP)
Adult participants will engage in the family-oriented Diabetes Prevention Program lifestyle intervention (Family DPP); this is an augmented version of the DPP lifestyle intervention. This 12-month, group-based lifestyle intervention will include all elements of the DPP lifestyle intervention as delivered by the Johns Hopkins Brancati Center using a CDC-approved curriculum, with additional child-focused sessions in which adult participants will learn about children's health-related behaviors. Children will be present at the child-focused sessions and family activities, and will be engaged in data collection. These groups will be "mixed," in that non-study participants (adults who are eligible for the DPP), may also participate.
干预措施: Family Diabetes Prevention Program (Family DPP) (Behavioral)
结局指标
主要结局
Recruitment Rate as Assessed by the Rate of Enrollment Per Week
时间窗: During recruitment period up to 22 weeks
Recruitment rate is calculated as the number of eligible participants (adult controls or adult-child dyad intervention arm) consenting and completing enrollment and participating in the trial, divided by period of recruitment (in weeks). This value is calculated separately for intervention arm and concurrent control group. The measure is calculated as # of participants recruited (total)/total number of weeks of recruitment. (For intervention arm, 12 adult-child dyads/22 weeks; for control arm adults: 10 adults/9.5 weeks).
Adult Participant Attendance in Program as Assessed by Total Number of Required Program Sessions Attended, Core
时间窗: 6 months
The average total number of required core period program sessions attended by the adult participant (inclusive of make-up sessions) including all DPP (and, if in Family DPP, additional Family DPP sessions); for Family DPP adult participants this will also be examined for the subset of DPP sessions and additional Family DPP sessions.
Adult Participant Attendance in Program as Assessed by Total Number of Program Sessions Attended, Full Program
时间窗: 12 months
The average total number of all required sessions attended by the adult participant (inclusive of make-up sessions); for Family DPP adult participants this will also be examined for the subset of DPP sessions only, and additional required Family DPP sessions only (of which there were 10), and didactic/required child-focused sessions only (of which there were 8).
Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Core
时间窗: 6 months
The average percentage of required core period program sessions attended by the adult participant (inclusive of make-up sessions) in each arm (denomiator of 18 for DPP, and 20 for Family DPP); for Family DPP adult participants this will also be examined for the subset of required DPP sessions only (denominator is 18) and additional Family DPP sessions only (of which there were 2).
Adult Participant Attendance in Program as Assessed by Percentage of Program Sessions Attended, Full Program
时间窗: 12 months
The percentage of all required program sessions attended by the adult participant (inclusive of make-up sessions); for Family DPP adult participants this will also be examined for the subset of DPP sessions only, all additional Family DPP sessions only (of which there were 10), and child-focused DPP sessions only (of which there were 8).
Feasibility of Measurement of Child-related Outcomes as Assessed by the Percentage of Total Child Participants for Whom Data Are Collected
时间窗: 12 months
The percentage of total enrolled child participants (in the Family DPP intervention arm) for whom BMI data and child-health behavior data are collected will be examined for the 12 month data point.
Child Participant Attendance in Family Diabetes Prevention Program
时间窗: 12 months
The percentage of required child-focused sessions (N=8) attended by the child participant will be examined for child participants in the Family DPP arm only.
Satisfaction With Family Diabetes Prevention Program as Assessed by Study Team Designed Questionnaire
时间窗: 12 months (end of intervention)
Mean Likert-scale score (for most items, Likert scale on a range of 1 to 4; from strongly disagree (1) to strongly agree (4)), exploring satisfaction with Family DPP content and structure). Mean of participant choice is reported.
Intervention Fidelity as Assessed by a Fidelity Checklist
时间窗: Up to 12 months
Using an adapted DPP fidelity checklist, this will examine fidelity of delivery of Family DPP specific sessions; percentage of content delivered by coach during session is reported.
Total Cost of Program Delivery
时间窗: 12 months (end of intervention)
Cost of program delivery (including staffing, materials, wrap-around support) per participant (or for FDPP, per dyad). Calculated separately for DPP and Family DPP (intervention) arm. Total delivery cost of DPP incurred by the delivering center was used for DPP cost/participant- this is calculated as a total cost for a set number of cohorts/participants, divided by number of participants. There is a single value (no variation) for each category of cost that was used to calculate this number, and thus no measure of precision or dispersion can be calculated due to nature of calculating a total cost. For FDPP dyads, additional costs related to FDPP intervention and delivery were included in this calculation.
Survey Administration Feasibility as Assessed by Mean Time for Administration of Surveys to Participants
时间窗: 12 months
Mean time (minutes) for administration of surveys to adult participant and child participant in the Family DPP (intervention) arm.
Feasibility of Measurement of Child-related Outcomes as Assessed by the Percentage of Total Child Participants for Whom Data Are Collected
时间窗: Baseline
The percentage of total enrolled child participants (in the intervention arm) for whom BMI data and also child-health behavior data are collected will be examined for at baseline data collection point.
Feasibility of Measurement of Child-related Outcomes as Assessed by the Percentage of Total Child Participants for Whom Data Are Collected
时间窗: 6 months
The percentage of total enrolled child participants (in the Family DPP interventionarm) for whom BMI data and also child-health behavior data are collected will be examined for the 6 month data point.
Survey Administration Feasibility as Assessed by Mean Time for Administration of Surveys to Participants
时间窗: Baseline
Mean time (minutes) for administration of baseline surveys to adult participant and child participant in the Family DPP (intervention) arm.
Survey Administration Feasibility as Assessed by Mean Time for Administration of Surveys to Participants
时间窗: 6 months
Mean time (minutes) for administration of surveys to adult participant and child participant at 6 month time point in the Family DPP (intervention) arm.
次要结局
- Percentage Change in Adult Participant Weight (Kilograms)(Baseline and 12 months (end of intervention))
- Change in Child Body Mass Index (BMI) Z-score(Baseline, 6 months and 12 months (end of intervention))
- Adult Participant Physical Activity as Assessed by Average Duration of Activity Per Week(12 months)
- Percentage of Adult Participants Who Met Physical Activity Achievement(12 months)
- Change in Adult Participant Dietary Pattern Related to Fruit and Vegetable Intake Frequency(Baseline, 6 months and 12 months (end of intervention))
- Change in Adult Participant Dietary Pattern Related to Sugary Beverage Intake Frequency(Baseline, 6 months and 12 months (end of intervention))
- Change in Child Participant Fruit and Vegetable Intake Frequency(Baseline, 6 months and 12 months (end of intervention))
- Change in Child Participant Sugary Beverage Intake Frequency(Baseline, 6 and 12 months)
- Change in Child Participant Screen Time(Baseline, 6 months and 12 months (end of intervention))
- Change in Child Participant Sleep Patterns(Baseline, 6 months and 12 months (end of intervention))
- Change in Adult Caregiver Perceived Self-efficacy for Behavioral Change(Baseline, 6 months and 12 months (end of intervention))
- Change in Child Participant Physical Activity Levels(Baseline, 6 months and 12 months (end of intervention))
- Change in Parenting Self-efficacy for Child Health Behavior Change(Baseline, 6 months and 12 months (end of intervention))
- Change in Family Eating/Activity Habits and Home Environment(Baseline, 6 months and 12 months (end of intervention))
- Change in Caregiver Knowledge Regarding Child Health Behaviors(Baseline, 6 months and 12 months (end of intervention))
- Change in Caregiver Attitudes Regarding Child Health Behaviors(Baseline, 6 months and 12 months (end of intervention))
- Adult Participant Physical Activity as Assessed by Average Duration of Activity Per Week(Baseline)
- Adult Participant Physical Activity as Assessed by Average Duration of Activity Per Week(6 months)