Project HERA (Health, Education, and Relationship-building for Adolescents- Moms and Tots) (Project HERA)
9 kwietnia 2015 zaktualizowane przez: 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.
Przegląd badań
Status
Zakończony
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
25
Faza
- Faza 2
- Faza 1
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Massachusetts
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Worcester, Massachusetts, Stany Zjednoczone, 01655
- UMASS
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
16 lat do 20 lat (Dziecko, Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Kobieta
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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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Aktywny komparator: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Study Feasibility
Ramy czasowe: 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
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Child Problem Behavior
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Child Weight Status (BMI percentile)
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 kwietnia 2013
Zakończenie podstawowe (Rzeczywisty)
1 września 2014
Ukończenie studiów (Rzeczywisty)
1 września 2014
Daty rejestracji na studia
Pierwszy przesłany
12 lipca 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
23 lipca 2014
Pierwszy wysłany (Oszacować)
25 lipca 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
10 kwietnia 2015
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
9 kwietnia 2015
Ostatnia weryfikacja
1 kwietnia 2015
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 14864
- R21HL114083 (Grant/umowa NIH USA)
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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