Family Diabetes Prevention Program Pilot Study

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).

Time frame: 6 months

Population: Adult participants in the DPP group and Family DPP group, who did not formally withdraw from the study.

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).

Time frame: 12 months

Population: Adult participants in the DPP group and Family DPP group, who did not formally withdraw from the study.

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).

Time frame: 12 months

Population: Adult participants in the DPP group and Family DPP group, who did not formally withdraw from the study.

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.

Time frame: 6 months

Population: Adult participants in the DPP group and Family DPP group, who did not formally withdraw from the study.

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.

Time frame: 12 months

Population: Child participants (who were enrolled in the Family DPP only), who did not formally withdraw from the study

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.

Time frame: 12 months

Population: There are no child participants in the DPP arm.

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.

Time frame: Baseline

Population: Enrolled child participants in the Family DPP arm.

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.

Time frame: 6 months

Population: Enrolled child participants in the Family DPP Arm, who had not formally withdrawn from the study.

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.

Time frame: Up to 12 months

Population: The units analyzed are FDPP sessions.

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).

Time frame: During recruitment period up to 22 weeks

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.

Time frame: 12 months (end of intervention)

Population: Adult participants in the Family DPP (intervention arm) only who completed the FDPP satisfaction survey.

Mean time (minutes) for administration of surveys to adult participant and child participant at 6 month time point in the Family DPP (intervention) arm.

Time frame: 6 months

Population: Data was not able to be collected, as measurement of time required for administration was unable to be assessed by study team member while simultaneously administering surveys.

Mean time (minutes) for administration of baseline surveys to adult participant and child participant in the Family DPP (intervention) arm.

Time frame: Baseline

Population: Data was not able to be collected, as measurement of time required for administration was unable to be assessed by study team member while simultaneously administering surveys.

Mean time (minutes) for administration of surveys to adult participant and child participant in the Family DPP (intervention) arm.

Time frame: 12 months

Population: Data was not able to be collected, as measurement of time required for administration was unable to be assessed by study team member while simultaneously administering surveys.

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.

Time frame: 12 months (end of intervention)

Average number of minutes/week of moderate-vigorous physical activity by self report, at 6 months (during core period) among adults for whom data was collected through this time point (this reflects average of values reported Sessions 2 through 18).

Time frame: 6 months

Population: Among adult study participants for whom data was collected through the time point as described (and who did not formally withdraw from the study)

Average number of minutes/week of moderate-vigorous physical activity by self report, by 12 months/end of program, among adults considered DPP completers (this reflects average of values reported Sessions 2 through 29).

Time frame: 12 months

Population: Among adult study participants considered as per specific Diabetes Prevention Program definition to have been completers in the DPP.

Average number of minutes/week of moderate-vigorous physical activity by self report, at baseline.

Time frame: Baseline

Population: This outcome was assessed among adult study participants in either the control or intervention arm for whom data was collected at the baseline time point AND who did not formally withdraw from the study.

Questionnaire exploring confidence in achieving behavioral goals related to physical activity, sleep and dietary modifications, using a Likert scale with options from 1 to 5, higher scores indicating higher perceived self-efficacy). Mean change in self-efficacy for each item from baseline (to 6 months and 12 months) will be assessed for adults in the Family DPP (intervention) arm.

Time frame: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among adult study participants in the intervention arm only; outcome was calculated for adult participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.~(This data was not collected in the control arm).

Questions from the Behavioral Risk Factor Surveillance System (BRFSS) 2017 modules on fruit, vegetable and fruit juice intake as assessed by participant recall (for 1 week period), which quantify frequency of intake of these food items over 1 week-recall period; changes in intake patterns from baseline, at 6 and 12 months, will be assessed for adults in the Family DPP (intervention) arm.

Time frame: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among adult study participants in the intervention arm only; outcome was calculated for adult participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.~(This data was not collected in the control arm).

Questions from the BRFSS on sugary beverage intake, as assessed by participant recall (for 1 week period), which quantify frequency of intake of sugary beverages over 1 week-recall period; changes in intake patterns from baseline, at 6 and 12 months, will be assessed for adults in the Family DPP (intervention) arm.

Time frame: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among adult study participants in the intervention arm only; outcome was calculated for adult participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.~(This data was not collected in the control arm).

Questionnaire examining caregiver beliefs and attitudes towards age-specific guidelines for sleep, dietary intake, screen time and physical activity, using a Likert scale for extent to which respondent agrees or disagrees with statements (Likert Scale Options of 1-4: 1-Strongly Disagree to 4-Strongly Agree). Higher score indicates higher agreement with the statement. Mean change in score for each from baseline examined for adults in the Family DPP (intervention) arm.

Time frame: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among adult study participants in the intervention arm only; outcome was calculated for adult participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.~(This data was not collected in the control arm).

Questionnaire examining knowledge or awareness of age-specific pediatric guidelines for sleep, dietary intake, screen time and physical activity. 4 total questions, with percentage of questions answered correctly ranging from 0% to 100%. Mean change in the percentage of questions answered correctly from baseline, will be examined for adults in the Family DPP (intervention) arm.

Time frame: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among adult study participants in the intervention arm only; outcome was calculated for adult participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.~(This data was not collected in the control arm).

Change in Centers for Disease Control and Prevention's extended Body Mass Index (BMI) z-score at end of program (12 months) compared to baseline and 6 months, from BMI calculated from weight and height measurements during program in the Family DPP (intervention) arm. (Z-score of 0 indicates population mean value). Calculated for all children and among subgroup of children with overweight or obese weight status at baseline.

Time frame: Baseline, 6 months and 12 months (end of intervention)

Population: Children in the Family DPP (intervention) arm only who did not formally withdraw from the study and for whom data was collected at relevant time points; there were no children enrolled in the DPP (control) arm.

Questions from the YRBS 2017 modules on fruit and vegetable intake, which quantify intake of these food items over a 7-day period; questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. Changes in intake patterns from baseline will be assessed.

Time frame: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among child study participants (in the intervention arm only; there were no children enrolled in the DPP (control arm); outcome was calculated for child participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.

Adaptations of questions from YRBS regarding number of days meeting physical activity goal/week. Questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. Changes in activity patterns from baseline, including whether meeting daily physical activity guidelines, will be assessed for children in the Family DPP (intervention) arm.

Time frame: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among child study participants (in the intervention arm only; there were no children enrolled in the DPP (control arm); outcome was calculated for child participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.

Adaptation of questions from YRBSS regarding average number of hours of screen time/day, asked weekday or weekend over past 7 days. Questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. (Options given of less than 1 hour, coded as 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours and 5 hours or more (coded as 5 hours). Changes in number of hours of screen time from baseline, at 6 and 12 months, will be assessed for children in the Family DPP (intervention) arm.

Time frame: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among child study participants (in the intervention arm only; there were no children enrolled in the DPP (control arm); outcome was calculated for child participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.

Adaptation of questions from YRBSS regarding average number of hours of sleep per night on weekdays, over last week. Questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. Changes will be assessed, at 6 and 12 months.

Time frame: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among child study participants (in the intervention arm only; there were no children enrolled in the DPP (control arm); outcome was calculated for child participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.

Questions from the Youth Risk Behavioral Surveillance System (YRBSS) on sugary beverage intake frequency over a 7-day period; questions will be asked of caregivers of all child participants and directly of children ages 9 through 12 years. Changes in intake patterns from baseline, at 6 and 12 months, will be assessed.

Time frame: Baseline, 6 and 12 months

Population: This outcome was assessed among child study participants (in the intervention arm only; there were no children enrolled in the DPP (control arm); outcome was calculated for child participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.

The Family Eating and Activity Habits Questionnaire-Revised (FEAHQ-R) is a 32-item, self-report instrument; score range 0-128 with likert scale options 0-4. It is a clinical tool that captures family member eating and activity habits and also factors related with obesity in the overall home environment for children and caregivers. A higher score is associated with less favorable or appropriate patterns. Mean changes in scores from baseline, at 6 and 12 months, will be assessed in the Family DPP (intervention) arm.

Time frame: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among adult AND child study participants in the intervention arm only; outcome was calculated for adult and child participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.~(This data was not collected in the control arm).

Questionnaire exploring adult caregiver confidence in supporting child to achieve behavioral goals related to physical activity, sleep, screen time and diet, using a Likert scale from 1 to 5 with higher scores indicating higher perceived self-efficacy). Mean change in parenting self-efficacy overall and for each item from baseline, at 6 and 12 months, will be assessed for adults in the Family DPP (intervention) arm.

Time frame: Baseline, 6 months and 12 months (end of intervention)

Population: This outcome was assessed among adult study participants in the intervention arm only; outcome was calculated for adult participants for whom data was collected at referenced time points (e.g., baseline and 6 months, and baseline and 12 months) AND who did not formally withdraw from the study.~(This data was not collected in the control arm).

Percentage change in weight (kilograms) from baseline to end of program (Self-report from home weight may be used depending on program delivery modality). Calculated for adults who are considered DPP completers (requires having been in DPP at least 9 months and also attending at least 8 sessions in core period) per the DPP specific definition.

Time frame: Baseline and 12 months (end of intervention)

Population: Adults who are considered DPP completers (requires having been in DPP at least 9 months and also attending at least 8 sessions in core period) as per the DPP specific definition.

Whether or not the adult participant met the program goal of an average 150 minutes/week of moderate-vigorous physical activity.

Time frame: 12 months

Population: Adult participants considered DPP completers.