This proposal includes a prospective, parallel group, two-arm RCT with 264 adult-child dyads (adult age 18+, child ages 5-17 years) to examine the effectiveness of the Growing Healthy Hearts (GHH) intervention versus a wait list control on cardiovascular and behavioral health outcomes at 3-, 6- and 12-months follow-up (Aim 1). This proposal will also examine the effect of GHH on home fruit and vegetable (FV) availability, frequency of home-prepared meals that include FV, and child behaviors (FV intake and PA) at 3-, 6- and 12-month follow-up (Aim 2) and intervention implementation (Aim 3)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
264
This intervention examines the effectiveness of the Growing Healthy Hearts (GHH) intervention versus a wait list control on cardiovascular and behavioral health outcomes at 3-, 6- and 12-months follow-up.
Penn State College of Medicine
Hershey, Pennsylvania, United States
Dietary Intake: Fruit and vegetable (FV) intake
Trained interviewers at the Penn State Diet Assessment Center, will collect 24-hour dietary recalls (one weekday and one weekend day) by phone within one week of each scheduled study visit at 4 time points. Diet data will be analyzed using the Nutrition Data System for Research (NDSR)
Time frame: Baseline
Dietary Intake: Fruit and vegetable (FV) intake
Trained interviewers at the Penn State Diet Assessment Center, will collect 24-hour dietary recalls (one weekday and one weekend day) by phone within one week of each scheduled study visit at 4 time points. Data will be analyzed using the Nutrition Data System for Research (NDSR)
Time frame: 3 month
Dietary Intake: Fruit and vegetable (FV) intake
Trained interviewers at the Penn State Diet Assessment Center, will collect 24-hour dietary recalls (one weekday and one weekend day) by phone within one week of each scheduled study visit at 4 time points. Data will be analyzed using the Nutrition Data System for Research (NDSR)
Time frame: 6 month
Dietary Intake: Fruit and vegetable (FV) intake
Trained interviewers at the Penn State Diet Assessment Center, will collect 24-hour dietary recalls (one weekday and one weekend day) by phone within one week of each scheduled study visit at 4 time points. Data will be analyzed using the Nutrition Data System for Research (NDSR)
Time frame: 1 year follow up
Physical Activity - Fitbit activity volume via step count
This data will be collected via wrist worn Fitbit Inspire 3 devices
Time frame: Baseline
Physical Activity - Fitbit activity volume via step count
This data will be collected via wrist worn Fitbit Inspire 3 devices
Time frame: 3 month
Physical Activity - Fitbit activity volume via step count
This data will be collected via wrist worn Fitbit Inspire 3 devices
Time frame: 6 month
Physical Activity - Fitbit activity volume via step count
This data will be collected via wrist worn Fitbit Inspire 3 devices
Time frame: 1 year follow up
Biomarkers - total cholesterol
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: Baseline
Biomarkers - total cholesterol
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 3 month
Biomarkers - total cholesterol
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 6 month
Biomarkers - total cholesterol
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 1 year follow up
Biomarkers - HDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: Baseline
Biomarkers - HDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 3 month
Biomarkers - HDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 6 month
Biomarkers - HDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 1 year follow up
Biomarkers -LDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: Baseline
Biomarkers -LDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 3 month
Biomarkers -LDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 6 month
Biomarkers -LDL
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 1 year follow up
Biomarkers -HbA1c
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: Baseline
Biomarkers -HbA1c
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 3 month
Biomarkers -HbA1c
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 6 month
Biomarkers -HbA1c
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 1 year follow up
Biomarkers -triglycerides
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: Baseline
Biomarkers -triglycerides
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 3 month
Biomarkers -triglycerides
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 6 month
Biomarkers -triglycerides
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
Time frame: 1 year follow up
Blood Pressure
The blood pressure cuffs will be used to monitor participants' cardiovascular health. These devices will be used to collect blood pressure data at baseline, midpoint, and follow-up assessments.
Time frame: Baseline
Blood Pressure
The blood pressure cuffs will be used to monitor participants' cardiovascular health. These devices will be used to collect blood pressure data at baseline, midpoint, and follow-up assessments.
Time frame: 3 month
Blood Pressure
The blood pressure cuffs will be used to monitor participants' cardiovascular health. These devices will be used to collect blood pressure data at baseline, midpoint, and follow-up assessments.
Time frame: 6 month
Blood Pressure
The blood pressure cuffs will be used to monitor participants' cardiovascular health. These devices will be used to collect blood pressure data at baseline, midpoint, and follow-up assessments.
Time frame: 1 year follow up
Measure Height
Height measurement tools will be used to assess changes in participant height for BMI calculation.
Time frame: Baseline
Measure Weight
Scales will be used to measure participants' weight and monitor changes in weight status. Accurate weight measurements are essential for Aim 1 to assess the participants' risk for obesity and other cardiovascular conditions. This will be collected on adults and children
Time frame: Baseline
Measure Weight
Scales will be used to measure participants' weight and monitor changes in weight status. Accurate weight measurements are essential for Aim 1 to assess the participants' risk for obesity and other cardiovascular conditions. This will be collected on adults and children
Time frame: 3 month
Measure Weight
Scales will be used to measure participants' weight and monitor changes in weight status. Accurate weight measurements are essential for Aim 1 to assess the participants' risk for obesity and other cardiovascular conditions. This will be collected on adults and children
Time frame: 6 month
Measure Weight
Scales will be used to measure participants' weight and monitor changes in weight status. Accurate weight measurements are essential for Aim 1 to assess the participants' risk for obesity and other cardiovascular conditions. This will be collected on adults and children
Time frame: 1 year follow up
Household Food Security
18-item United States Household Food Security Survey Module will assess home food security for adults and children. Scale yields scores from 0-18 with lower scores indicating higher food security.
Time frame: Baseline
Household Food Security
18-item United States Household Food Security Survey Module will assess home food security for adults and children. Scale yields scores from 0-18 with lower scores indicating higher food security.
Time frame: 3 month
Household Food Security
18-item United States Household Food Security Survey Module will assess home food security for adults and children. Scale yields scores from 0-18 with lower scores indicating higher food security.
Time frame: 6 month
Household Food Security
18-item United States Household Food Security Survey Module will assess home food security for adults and children. Scale yields scores from 0-18 with lower scores indicating higher food security.
Time frame: 1 year follow up
General Nutrition Knowledge
General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
Time frame: Baseline
General Nutrition Knowledge
General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome).
Time frame: 3 month
General Nutrition Knowledge
General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
Time frame: 6 month
General Nutrition Knowledge
General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
Time frame: 1 year follow up
Home Meal Preparation
The National Health and Nutrition Examination Survey (NHANES) Home meal preparation questionnaire will assess the number of evening meals prepared per week (range 0-7 with higher number equating to more evening meals prepared).
Time frame: Baseline
Home Meal Preparation
The National Health and Nutrition Examination Survey (NHANES) Home meal preparation questionnaire will assess the number of evening meals prepared per week (range 0-7 with higher number equating to more evening meals prepared).
Time frame: 3 month
Home Meal Preparation
The National Health and Nutrition Examination Survey (NHANES) Home meal preparation questionnaire will assess the number of evening meals prepared per week (range 0-7 with higher number equating to more evening meals prepared).
Time frame: 6 month
Home Meal Preparation
The National Health and Nutrition Examination Survey (NHANES) Home meal preparation questionnaire will assess the number of evening meals prepared per week (range 0-7 with higher number equating to more evening meals prepared).
Time frame: 1 year follow up
Cooking skills
The Cooking and Food Skills Questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
Time frame: Baseline
Cooking skills
The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
Time frame: 3 month
Cooking skills
The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
Time frame: 6 month
Cooking skills
The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
Time frame: 1 year follow up
Social support
The Social Support for Diet and Exercise Behavior survey measures social support from friends and family with higher scores indicating more social support for these behaviors (score range 0-115).
Time frame: Baseline
Social support
The Social Support for Diet and Exercise Behavior survey measures social support from friends and family with higher scores indicating more social support for these behaviors (score range 0-115).
Time frame: 3 month
Social support
The Social Support for Diet and Exercise Behavior survey measures social support from friends and family with higher scores indicating more social support for these behaviors (score range 0-115).
Time frame: 6 month
Social support
The Social Support for Diet and Exercise Behavior survey measures social support from friends and family with higher scores indicating more social support for these behaviors (score range 0-115).
Time frame: 1 year follow up
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