Health TrialsbyHealthPanel

Growing Healthy Hearts

ConditionsCardiovascular (CV) RiskBehavioral ChangesGardeningCookingNutrition Education
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMilton S. Hershey Medical Center

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 or older who are interested in gardening but have no plans to garden in the coming season.

Participants will also be required to: 1) have at least one child (aged 5-17) living in the household with them

Have access to space for a garden (either at home or in a community garden space where they could plant any combination of in-ground, raised beds, and/or container gardens

Have a smartphone capable of downloading an app and syncing with a Fitbit

Disqualifiers

Adults who are pregnant

Have medical conditions that significantly limit an individual's ability to participate in gardening (e.g., knee or back pain, heart attack/stroke in the past year, recent or pending surgeries

Uncontrolled allergies, other serious physical disabilities, uncontrolled asthma)

Medical conditions that may limit participants from increasing FV intake (e.g., kidney failure or dialysis)

Trial design

Design model

Parallel

Treatments tested in this trial

  • GHH Intervention

    Behavioral

    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.

Treatment groups

264 Participants
are divided into 2 treatment groups
Group A: GHH InterventionExperimental treatment 1 intervention
Group B: Waitlist ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

Physical Activity - Fitbit activity volume via step count

This data will be collected via wrist worn Fitbit Inspire 3 devices

Time frame
Baseline
2

Physical Activity - Fitbit activity volume via step count

This data will be collected via wrist worn Fitbit Inspire 3 devices

Time frame
3 month
3

Physical Activity - Fitbit activity volume via step count

This data will be collected via wrist worn Fitbit Inspire 3 devices

Time frame
6 month
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Milton S. Hershey Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: