Growing Right Onto Wellness (GROW): Changing Early Childhood Body Mass Index (BMI) Trajectories (GROW)
調査の概要
詳細な説明
Increases in sedentary lifestyle and high calorie food consumption, among other factors, have contributed to epidemic levels of childhood obesity in the US. Children who are overweight during the preschool period are more likely to become overweight adolescents and obese adults. Food preferences and activity habits set in early childhood can profoundly influence lifelong trajectories for Body Mass Index (BMI) and health. Specifically, rapid BMI gain in early childhood has been established to affect adulthood mortality and morbidity. Unfortunately, the longer such unhealthy patterns are in place, the more difficult it can be to reverse them. Therefore, healthy lifestyle interventions targeted at children as early as preschool have enormous potential to affect lifelong health. Furthermore, nutrition and activity patterns are determined not only at the child level, but within the family and the community.
This study will assess the impact of a family-based and community centered multilevel behavioral intervention addressing nutrition and physical activity with high risk parent-preschool children dyads to promote pediatric obesity prevention. The 7 year study will follow 600 parent preschool child dyads, half of whom will be randomized into the intervention condition which will utilize a health literate approach, build new social networks, utilize behavior modification tools including goal setting, self monitoring, and problem solving, and create behavior-environmental synergy with cues to action for use of the built environment for healthy behaviors. Both the intervention and control group (separately) will receive the control condition in which parent-child dyads will receive a literacy promotion/school success curriculum.
The primary outcome of interest will be early childhood BMI trajectories measured at multiple time points over the three year RCT. Additional measures collected throughout the study from children and parents will include: tricep skin fold, waist circumference, actigraphy, 3-day diet recalls, questionnaires, social network data, and saliva to assess a genetics/epigenetics associated with obesity. Consistent with a multilevel systems approach, the investigators will develop and assess built environment changes related to obesity prevention. Moreover, working with the study's community partners, the investigators will evaluate how this approach affects local policy.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Tennessee
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Nashville、Tennessee、アメリカ、37232
- Vanderbilt University Medical Center
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- English or Spanish speaking
- Address in select zip code regions around participating Metro community centers
- Parental commitment to consistent participation
- Consistent phone access for 3 years
- Child aged 3-5 years old
- Child BMI ≥ 50% and < 95% (no diagnosis of failure to thrive or difficulty with appropriate weight gain)
- Healthy parent and child (without medical conditions necessitating limited physical activity)
- Parent ≥ 18 years of age
Exclusion Criteria:
- Non English or Spanish speaking
- Address outside select zip code regions around participating Metro community centers
- Lack of parental commitment to consistent participation
- Lack of consistent phone access
- Child outside specified age range
- Child BMI < 50% or ≥ 95%
- Parents and/or children who are diagnosed with medical illnesses where regular exercise might be contraindicated
- Parent < 18 years of age
研究計画
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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アクティブコンパレータ:GROW Smarter
Library based program to promote early literacy
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Group sessions that meet six times over the course of three years with quarterly newsletters.
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実験的:GROW Healthier
Healthy lifestyle intervention focused on building healthy lifestyle skills for preschool children and participating parents and building new social networks between the intervention group members.
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Group sessions that meet six times over the course of three years with quarterly newsletters.
Group sessions that meet once weekly for 3 months (intensive phase) with choice of phone call session as preferred by participant, phone call coaching monthly for 9 months (maintenance phase), and monthly cues to action to use one's built environment for healthy activities for 24 months (sustainability phase)
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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 |
時間枠 |
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Early Childhood BMI Trajectory
時間枠:Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
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Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
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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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Average daily energy intake (kcal)
時間枠:Baseline, 12 months, 24 months, and 36 months
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Baseline, 12 months, 24 months, and 36 months
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Percentage of Energy Intake from Fat
時間枠:Baseline, 12 months, 24 months, and 36 months
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Baseline, 12 months, 24 months, and 36 months
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Percentage of Energy Intake from Carbohydrates
時間枠:Baseline, 12 months, 24 months, and 36 months
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Baseline, 12 months, 24 months, and 36 months
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Percentage of Energy Intake from Protein
時間枠:Baseline, 12 months, 24 months, and 36 months
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Baseline, 12 months, 24 months, and 36 months
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Average daily time (minutes) spent in rest and sedentary behavior
時間枠:Baseline, 12 months, 24 months, and 36 months
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Baseline, 12 months, 24 months, and 36 months
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Average daily time (minutes) spent in moderate and vigorous physical activity
時間枠:Baseline, 12 months, 24 months, and 36 months
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Baseline, 12 months, 24 months, and 36 months
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Parent community center use with child
時間枠:Baseline, 12 months, 24 months, and 36 months
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never versus at least once
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Baseline, 12 months, 24 months, and 36 months
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Parent BMI
時間枠:Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
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Baseline, 3 months, 9 months, 12 months, 24 months, and 36 months
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Parent Waist Circumference
時間枠:Baseline, 12 months, 24 months, and 36 months
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Baseline, 12 months, 24 months, and 36 months
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Parent Triceps Skinfold
時間枠:Baseline, 12 months, 24 months, and 36 months
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Baseline, 12 months, 24 months, and 36 months
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Child Waist Circumference
時間枠:Baseline, 12 months, 24 months, and 36 months
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Baseline, 12 months, 24 months, and 36 months
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Child Triceps Skinfold
時間枠:Baseline, 12 months, 24 months, and 36 months
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Baseline, 12 months, 24 months, and 36 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Social Network
時間枠:Baseline, 3 months, 12 months, and 36 months
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Ties between participants
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Baseline, 3 months, 12 months, and 36 months
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者:Shari Barkin, MD, MSHS、Vanderbilt University Medical Center
出版物と役立つリンク
一般刊行物
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- Reinert KR, Po'e EK, Barkin SL. The relationship between executive function and obesity in children and adolescents: a systematic literature review. J Obes. 2013;2013:820956. doi: 10.1155/2013/820956. Epub 2013 Feb 21.
- White RO, Thompson JR, Rothman RL, McDougald Scott AM, Heerman WJ, Sommer EC, Barkin SL. A health literate approach to the prevention of childhood overweight and obesity. Patient Educ Couns. 2013 Dec;93(3):612-8. doi: 10.1016/j.pec.2013.08.010. Epub 2013 Aug 19.
- Gesell SB, Barkin SL, Sommer EC, Thompson JR, Valente TW. Increases in Network Ties Are Associated With Increased Cohesion Among Intervention Participants. Health Educ Behav. 2016 Apr;43(2):208-16. doi: 10.1177/1090198115599397. Epub 2015 Aug 17.
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- Heerman WJ, White RO, Hotop A, Omlung K, Armstrong S, Mathieu I, Sherwood NE, Barkin SL. A Tool Kit to Enhance the Informed Consent Process for Community-Engaged Pediatric Research. IRB. 2016 Sep-Oct;38(5):8-14. No abstract available.
- Heerman WJ, Berge JM, Barkin SL. Mentoring of Early-Stage Investigators When Funding Is Tight: The Childhood Obesity Prevention and Treatment Research Experience. JAMA Pediatr. 2018 Jan 1;172(1):4-6. doi: 10.1001/jamapediatrics.2017.3396. No abstract available.
- Heerman WJ, Lounds-Taylor J, Mitchell S, Barkin SL. Validity of the toddler feeding questionnaire for measuring parent authoritative and indulgent feeding practices which are associated with stress and health literacy among Latino parents of preschool children. Nutr Res. 2018 Jan;49:107-112. doi: 10.1016/j.nutres.2017.10.018. Epub 2017 Nov 3.
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- Fletcher GE, Teeters L, Schlundt D, Bonnet K, Heerman WJ. Maternal conception of gestational weight gain among Latinas: A qualitative study. Health Psychol. 2018 Feb;37(2):132-138. doi: 10.1037/hea0000555. Epub 2017 Oct 2.
- van Bakergem M, Sommer EC, Heerman WJ, Hipp JA, Barkin SL. Objective reports versus subjective perceptions of crime and their relationships to accelerometer-measured physical activity in Hispanic caretaker-child dyads. Prev Med. 2017 Feb;95 Suppl:S68-S74. doi: 10.1016/j.ypmed.2016.12.001. Epub 2016 Dec 6.
- Barkin SL, Lamichhane AP, Banda JA, JaKa MM, Buchowski MS, Evenson KR, Bangdiwala SI, Pratt C, French SA, Stevens J. Parent's Physical Activity Associated With Preschooler Activity in Underserved Populations. Am J Prev Med. 2017 Apr;52(4):424-432. doi: 10.1016/j.amepre.2016.11.017. Epub 2017 Jan 9.
- Heerman WJ, Taylor JL, Wallston KA, Barkin SL. Parenting Self-Efficacy, Parent Depression, and Healthy Childhood Behaviors in a Low-Income Minority Population: A Cross-Sectional Analysis. Matern Child Health J. 2017 May;21(5):1156-1165. doi: 10.1007/s10995-016-2214-7.
- Oelsner KT, Guo Y, To SB, Non AL, Barkin SL. Maternal BMI as a predictor of methylation of obesity-related genes in saliva samples from preschool-age Hispanic children at-risk for obesity. BMC Genomics. 2017 Jan 9;18(1):57. doi: 10.1186/s12864-016-3473-9.
- Stevens J, Pratt C, Boyington J, Nelson C, Truesdale KP, Ward DS, Lytle L, Sherwood NE, Robinson TN, Moore S, Barkin S, Cheung YK, Murray DM. Multilevel Interventions Targeting Obesity: Research Recommendations for Vulnerable Populations. Am J Prev Med. 2017 Jan;52(1):115-124. doi: 10.1016/j.amepre.2016.09.011. Epub 2016 Oct 26.
- Heerman WJ, Mitchell SJ, Thompson J, Martin NC, Sommer EC, van Bakergem M, Taylor JL, Buchowski MS, Barkin SL. Parental perception of built environment characteristics and built environment use among Latino families: a cross-sectional study. BMC Public Health. 2016 Nov 22;16(1):1180. doi: 10.1186/s12889-016-3854-7.
- Mathieu NP, Sommer EC, Mitchell SJ, Barkin SL. Urban Latino Families' Food Built Environment and Young Children's Produce Consumption. J Health Care Poor Underserved. 2016;27(4):1899-1908. doi: 10.1353/hpu.2016.0170.
- Heerman WJ, White RO, Barkin SL. Advancing informed consent for vulnerable populations. Pediatrics. 2015 Mar;135(3):e562-4. doi: 10.1542/peds.2014-3041. No abstract available.
- Ruiz RM, Sommer EC, Tracy D, Banda JA, Economos CD, JaKa MM, Evenson KR, Buchowski MS, Barkin SL. Novel patterns of physical activity in a large sample of preschool-aged children. BMC Public Health. 2018 Feb 13;18(1):242. doi: 10.1186/s12889-018-5135-0.
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研究記録日
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研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
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最終確認日
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