Project HERA (Health, Education, and Relationship-building for Adolescents- Moms and Tots) (Project HERA)
9. dubna 2015 aktualizováno: University of Massachusetts, Worcester
Helping Ethnically Diverse Teen Moms Prevent Obesity in Their Preschool Children
Specific Aims:
- The primary aims of this study are to conduct formative interviews with teen mothers to inform a targeted adaptation of empirically based weight management and parent training programs for teen mothers for their preschoolers.
- To conduct a small pilot and post-pilot focus group of the feasibility and acceptability of recruitment and retention methods & the intervention.
Study Hypotheses:
Given the small sample size and fact that this is a pilot study, focus will be on estimating effect sizes rather than statistical hypothesis testing. However, the investigators exploratory hypotheses are as follows:
- (a) The adapted intervention will be more feasible compared to the wellness control condition, with a participant retention rate of ≥80% and an average adherence (attendance at weekly treatment sessions; homework completion 5 weekdays weekly) is ≥ 75%; (b) The adapted intervention will be more acceptable compared to the wellness control condition, based on the Consumer Satisfaction Scale and Therapy Assessment Inventory with ≥90% of the participants responding to the item, "In general how satisfied were you with the intervention?" by choosing "unsatisfied" to "very satisfied."
- (a) The adapted intervention will result in greater improvements in child behavior and parent-child connectedness compared to the control condition; (b) the adapted intervention versus wellness control condition will result in greater increases in child and teen mother individual as well as joint physical activity and physically active play and greater reductions in individual and joint teen mother and child sedentary behavior (television viewing) from baseline to post-intervention; (c) the greater teen mother and child fruit and vegetable consumption; and reduced child juice and sugar-sweetened beverage consumption from baseline to post-intervention; (d) the adapted intervention versus wellness control condition will result in smaller increases in child BMI percentile and teen mother BMI from baseline to post-intervention; (e) participants who attend higher numbers of intervention sessions will show greater improvements in target outcomes (child behavior, parent-child connectedness, and teen mother and child physical activity, sedentary behavior and BMI); with participants receiving the adapted intervention versus wellness control showing the greatest dose-based improvements.
Přehled studie
Postavení
Dokončeno
Typ studie
Intervenční
Zápis (Aktuální)
25
Fáze
- Fáze 2
- Fáze 1
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Massachusetts
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Worcester, Massachusetts, Spojené státy, 01655
- UMASS
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
16 let až 20 let (Dítě, Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Ženský
Popis
Inclusion Criteria:
- Must be teen moms
- Be between 16 and 20 years of age
Exclusion Criteria:
- Does not have a child between the ages of 6 months and 5 years
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Parent Training/Obesity Prevention
Mother-child dyads randomized to the active intervention in the pilot study will be administered 8 weeks of a combined parenting training and obesity prevention program that was adapted through analysis of formative research interviews with adolescent mothers with feedback from an expert panel of multidisciplinary research team members and community members.
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Aktivní komparátor: 8-week Wellness Program (Control)
Participants randomized to control condition during intervention piloting will receive print-based health and wellness materials once weekly for 8-weeks + 2 follow up telephone calls at the beginning and conclusion of the 8-week program.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Study Feasibility
Časové okno: Measured at the beginning of participant recruitment through 8 weeks follow up (end of treatment)
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Feasibility will be assessed during intervention piloting using process evaluation data to determine the pace of recruitment relative to sample size goals and differences in retention by condition.
Descriptive analyses will determine the % of participants recruited, rate of accrual, attrition rate over time and total, % accepting randomization to treatment, and % compliance with study protocols (as measured by number of sessions attended, number who complete homework, etc…).
Due to the small sample size in the current study, the intervention will be considered feasible if the retention rate is ≥ 80% and if the average adherence (attendance at weekly treatment sessions; homework completion 5 weekdays weekly) is ≥ 75%.
The post pilot focus group will probe participants about their perspective on methods used to recruitment them into the study, including advertisements, incentives, location etc...
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Measured at the beginning of participant recruitment through 8 weeks follow up (end of treatment)
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Study Acceptability
Časové okno: 8-weeks follow up (end of treatment)
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We will assess study acceptability via maternal completion of customer satisfaction questionnaires at the end of treatment (8 weeks follow up) for participants randomized (n=46) during intervention piloting to the adapted intervention (combined parenting/obesity prevention program) versus control condition (wellness program).
We will invite a subsample of n=8 adolescent mothers to participate in the post-pilot focus group to further assess study acceptability and probe these participants on the likes and dislikes for the program, and recruitment methods.
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8-weeks follow up (end of treatment)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Child Problem Behavior
Časové okno: Baseline, Each week for 8 weeks during active treatment, and 8-weeks follow up (end of treatment)
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We will assess for changes in child problem behavior via maternal completion of child behavior questionnaires administered at baseline, once weekly for eight weeks during active intervention, and at 8 weeks end of treatment (follow up) for participants randomized (n= 46) to the intervention arm (parenting/combined obesity prevention program) versus control (wellness condition).
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Baseline, Each week for 8 weeks during active treatment, and 8-weeks follow up (end of treatment)
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Change in Child Physical Activity/Sedentary Behavior
Časové okno: Baseline, 8-weeks follow up (end of treatment)
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Child physical activity and sedentary behavior will be measured via maternal completion of questionnaires administered at baseline and 8 weeks follow up to assess for changes in these outcomes across participants randomized during intervention piloting (n=46) to the intervention condition (combined parenting/obesity prevention program) versus control condition (wellness program).
Child physical activity and sedentary behavior will also be assessed via a home audit of the home physical activity/sedentary behavior environment completed by the research assistant at baseline and 8-weeks follow up (end of treatment)
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Baseline, 8-weeks follow up (end of treatment)
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Change in Child fruit, Vegetable, Junk, Fat and Fast food Intake (Child Nutritional Behavior)
Časové okno: Baseline, 8-weeks follow up (end of treatment)
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Child nutritional behavior will be measured via maternal completion of questionnaires administered at baseline and 8 weeks follow up to assess for changes in these outcomes across participants randomized during intervention piloting (n=46) to the adapted intervention condition (combined parenting/obesity prevention program) versus control condition (wellness program).
Child nutritional behavior will also be assessed via a home audit completed by the research assistant at baseline and 8-weeks follow up (end of treatment).
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Baseline, 8-weeks follow up (end of treatment)
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Change in Child Weight Status (BMI percentile)
Časové okno: Baseline, 8-weeks follow up (end of treatment)
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We will measure child height and weight at baseline and 8-weeks follow up (end of treatment) to calculate child BMI percentile to assess for changes in BMI percentile for participants randomized during intervention piloting (n=46) to the adapted intervention condition (combined parenting/obesity prevention program) compared to those in the control condition (wellness program).
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Baseline, 8-weeks follow up (end of treatment)
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. dubna 2013
Primární dokončení (Aktuální)
1. září 2014
Dokončení studie (Aktuální)
1. září 2014
Termíny zápisu do studia
První předloženo
12. července 2014
První předloženo, které splnilo kritéria kontroly kvality
23. července 2014
První zveřejněno (Odhad)
25. července 2014
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
10. dubna 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
9. dubna 2015
Naposledy ověřeno
1. dubna 2015
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 14864
- R21HL114083 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .
Klinické studie na Combined parent training and obesity prevention program
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