Growing Healthy Hearts (GHH)
2026年7月2日 更新者：Susan Veldheer、Milton S. Hershey Medical Center
Growing Healthy Hearts: A Randomized Controlled Trial of a Multicomponent Gardening Intervention for Adults With Cardiovascular Disease Risk and Their Families.
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)
調査の概要
研究の種類
介入
入学 (推定)
264
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Susan Veldheer, DEd, RD
- 電話番号：717-531-5625
- メール：sveldheer@psu.edu
研究連絡先のバックアップ
- 名前：Kayla Rutt, DrPH
- 電話番号：717-858-6204
- メール：krutt1@pennstatehealth.psu.edu
研究場所
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Pennsylvania
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Hershey、Pennsylvania、アメリカ、17033
- Penn State College of Medicine
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- 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
- Access to the internet
- Have or are willing to create a Facebook account
- Report ≤90 minutes of moderate or vigorous physical activity /week
- Report <5 servings of fruit and vegetables per day
- Have any one additional self-reported CVD risk factor (e.g., BMI ≥25, family history of premature CVD, high blood pressure, high cholesterol, diabetes, current or past tobacco use)
Exclusion Criteria:
- 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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：キャンセル待ち管理
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実験的：GHH Intervention
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Dietary Intake: Fruit and vegetable (FV) intake
時間枠：Baseline
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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)
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Baseline
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Dietary Intake: Fruit and vegetable (FV) intake
時間枠：3 month
|
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)
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3 month
|
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Dietary Intake: Fruit and vegetable (FV) intake
時間枠：6 month
|
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)
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6 month
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Dietary Intake: Fruit and vegetable (FV) intake
時間枠：1 year follow up
|
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)
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1 year follow up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physical Activity - Fitbit activity volume via step count
時間枠：Baseline
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This data will be collected via wrist worn Fitbit Inspire 3 devices
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Baseline
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Physical Activity - Fitbit activity volume via step count
時間枠：3 month
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This data will be collected via wrist worn Fitbit Inspire 3 devices
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3 month
|
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Physical Activity - Fitbit activity volume via step count
時間枠：6 month
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This data will be collected via wrist worn Fitbit Inspire 3 devices
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6 month
|
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Physical Activity - Fitbit activity volume via step count
時間枠：1 year follow up
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This data will be collected via wrist worn Fitbit Inspire 3 devices
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1 year follow up
|
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Biomarkers - total cholesterol
時間枠：Baseline
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These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
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Biomarkers - total cholesterol
時間枠：3 month
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These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
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3 month
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Biomarkers - total cholesterol
時間枠：6 month
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These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
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6 month
|
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Biomarkers - total cholesterol
時間枠：1 year follow up
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These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
1 year follow up
|
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Biomarkers - HDL
時間枠：Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers - HDL
時間枠：3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers - HDL
時間枠：6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers - HDL
時間枠：1 year follow up
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
1 year follow up
|
|
Biomarkers -LDL
時間枠：Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers -LDL
時間枠：3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -LDL
時間枠：6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
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Biomarkers -LDL
時間枠：1 year follow up
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These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
1 year follow up
|
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Biomarkers -HbA1c
時間枠：Baseline
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These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
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Biomarkers -HbA1c
時間枠：3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
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Biomarkers -HbA1c
時間枠：6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
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Biomarkers -HbA1c
時間枠：1 year follow up
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These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
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1 year follow up
|
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Biomarkers -triglycerides
時間枠：Baseline
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These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
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Biomarkers -triglycerides
時間枠：3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -triglycerides
時間枠：6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
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Biomarkers -triglycerides
時間枠：1 year follow up
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
1 year follow up
|
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Blood Pressure
時間枠：Baseline
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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.
|
Baseline
|
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Blood Pressure
時間枠：3 month
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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.
|
3 month
|
|
Blood Pressure
時間枠：6 month
|
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.
|
6 month
|
|
Blood Pressure
時間枠：1 year follow up
|
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.
|
1 year follow up
|
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Measure Height
時間枠：Baseline
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Height measurement tools will be used to assess changes in participant height for BMI calculation.
|
Baseline
|
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Measure Weight
時間枠：Baseline
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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
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Baseline
|
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Measure Weight
時間枠：3 month
|
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
|
3 month
|
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Measure Weight
時間枠：6 month
|
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
|
6 month
|
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Measure Weight
時間枠：1 year follow up
|
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
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1 year follow up
|
|
Household Food Security
時間枠：Baseline
|
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.
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Baseline
|
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Household Food Security
時間枠：3 month
|
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.
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3 month
|
|
Household Food Security
時間枠：6 month
|
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.
|
6 month
|
|
Household Food Security
時間枠：1 year follow up
|
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.
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1 year follow up
|
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General Nutrition Knowledge
時間枠：Baseline
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General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
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Baseline
|
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General Nutrition Knowledge
時間枠：3 month
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General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome).
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3 month
|
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General Nutrition Knowledge
時間枠：6 month
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General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
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6 month
|
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General Nutrition Knowledge
時間枠：1 year follow up
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General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
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1 year follow up
|
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Home Meal Preparation
時間枠：Baseline
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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).
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Baseline
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Home Meal Preparation
時間枠：3 month
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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).
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3 month
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Home Meal Preparation
時間枠：6 month
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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).
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6 month
|
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Home Meal Preparation
時間枠：1 year follow up
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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).
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1 year follow up
|
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Cooking skills
時間枠：Baseline
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The Cooking and Food Skills Questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
|
Baseline
|
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Cooking skills
時間枠：3 month
|
The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
|
3 month
|
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Cooking skills
時間枠：6 month
|
The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
|
6 month
|
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Cooking skills
時間枠：1 year follow up
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The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
|
1 year follow up
|
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Social support
時間枠：Baseline
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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).
|
Baseline
|
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Social support
時間枠：3 month
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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).
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3 month
|
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Social support
時間枠：6 month
|
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).
|
6 month
|
|
Social support
時間枠：1 year follow up
|
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).
|
1 year follow up
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2030年10月1日
研究の完了 (推定)
2031年3月1日
試験登録日
最初に提出
2026年6月29日
QC基準を満たした最初の提出物
2026年6月29日
最初の投稿 (実際)
2026年7月6日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月7日
QC基準を満たした最後の更新が送信されました
2026年7月2日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。