iAmHealthy Parents First: Televideo Program pro rodičovskou a dětskou obezitu pro rodiny ve venkovském Kansasu
The purpose of this study is to assess whether providing a parent-only group program before providing a parent and child group program works better than the parent and child group program alone.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
The goal of this project is to determine if an adult intervention followed by a family-based program (iAmHealthy Parents First) will result in a larger percentage of weight loss in parents and children compared to solely a family-based program (iAmHealthy). Furthermore, the investigators aim to discover if administering iAmHealthy Parents First will improve dietary intake, physical activity, and weight-related quality of life among parents and children when compared to iAmHealthy. Parent/child dyads will be recruited from rural elementary schools, medical clinics, and organizations across Kansas and neighboring states.
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
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Kansas
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Kansas City, Kansas, Spojené státy, 66160
- University of Kansas Medical Center
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Family lives in a rural area (city and/or county population <20,000) or as defined by RUCA codes, Urban Influence Codes, amount of agricultural income, or individual commuting patterns
- Child BMI%ile ≥ 85th and parent BMI 25-50 kg/m2
- Child in 1st-5th grade or 6-11 years of age
- Child and parent speak English
- Family is available at times intervention is offered
Exclusion Criteria:
- For parents: new MI, stroke or cancer diagnosis in past 6 months, recent bariatrics surgery (within 2 years) or planned within 1 year, pregnancy in last 6 months or planned within 1 year
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Experimentální: iAmHealthy Parents First
iAmHealthy Parents First families will take part in a group program with other adults over Zoom. Children will not be involved during this time. Adults will participate in these group sessions weekly for three months. Each meeting will last approximately an hour. Half of the dyads from each cohort will be randomized to the iAmHealthy Parents First group. After 3 months, both iAmHealthy Parents First and iAmHealthy families will take part in an educational group program with parents and their children. These meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur three weeks out of four for four months. There will be three additional family-based group sessions spread over the final two months of the program. iAmHealthy Parents First adults will continue to meet monthly during the family-based program (on weeks when the family-based group does not meet) to continue the adult program. |
iAmHealthy Parents first is a 3-month adult obesity treatment program targeting the unique needs of adults with school-age children. Following the iAmHealthy Parents First program, these dyads will take part in a 6-month family-based healthy lifestyles program. |
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Aktivní komparátor: iAmHealthy
iAmHealthy families will receive an informational newsletter once a month for three months. This group will be given the flexibility to start their weight loss journey using self-guided methods. No formal group sessions will be provided for three months. Half of the dyads from each cohort will be randomized to the iAmHealthy group. After 3 months, both iAmHealthy Parents First and iAmHealthy families will take part in an educational group program with parents and their children. These meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur three weeks out of four for four months. There will be three additional family-based group sessions spread over the final two months of the program. |
The iAmHealthy group will receive newsletters for three months. Following this period, these dyads will take part in a 6-month family-based healthy lifestyles program. |
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Jiný: iAmHealthy Parents First, Pilot, Non-Randomized
Non-randomized feasiblity group. iAmHealthy Parents First families will take part in a group program with other adults over Zoom. Children will not be involved during this time. Adults will participate in these group sessions weekly for three months. Each meeting will last approximately an hour. After 3 months, families will take part in an educational group program with parents and their children. These meetings will be focused on living healthy lifestyles and engaging in healthy habits as a family and will occur three weeks out of four for four months. There will be three additional family-based group sessions spread over the final two months of the program. Adults will continue to meet monthly during the family-based program (on weeks when the family-based group does not meet) to continue the adult program. |
iAmHealthy Parents first is a 3-month adult obesity treatment program targeting the unique needs of adults with school-age children. Following the iAmHealthy Parents First program, these dyads will take part in a 6-month family-based healthy lifestyles program. |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Percent weight change in parents and BMIz (BMI z-score) in children
Časové okno: Baseline, 3 months, 9 months
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Parents and children will measure body weight on a study-provided digital scale following instructions provided by study team. |
Baseline, 3 months, 9 months
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Mediator: Attendance
Časové okno: Baseline, 3 months, 9 months
|
Group and individual session attendance (percent of sessions) will be tracked on REDCap, a secure, web-based application designed exclusively to support data capture for research studies. |
Baseline, 3 months, 9 months
|
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Mediator: Reciprocal modeling
Časové okno: Baseline, 3 months, 9 months
|
Reciprocal influence (parent response as mediator for child; child response as mediator for parent) will be operationalized as adult or child weight loss. |
Baseline, 3 months, 9 months
|
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Moderator: Family functioning
Časové okno: Baseline, 3 months, 9 months
|
Family functioning will be measured using the Family Assessment Device (FAD). This is the gold-standard measure of structural, organizational, and transactional characteristics of families including general family functioning (core scale of interest) and 6 additional subscales: affective involvement, affective responsiveness, behavioral control, communication, problem solving, and roles. This questionnaire will be completed by adults. The FAD is scored by adding responses of each scale (1 - 4) and dividing by the number of items in each scale (between 6 - 12). The higher the overall score, the worse the level of family function. |
Baseline, 3 months, 9 months
|
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Moderators: Genetic casual attributions
Časové okno: Baseline, 3 months, 9 months
|
Genetic casual attributions will be measured using a a 2-item Likert scale that assesses perceived genetic role for weight status and potential for weight loss. This will be completed by adults. Those who endorse completely or mostly for the role of genes in weight loss will be characterized as having "high genetic attribution" for weight status. |
Baseline, 3 months, 9 months
|
Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Participation rates and representativeness of enrolled participants
Časové okno: 9 months
|
Reach (participation rates and representativeness) will be assessed across recruitment methods. Participation rates will be calculated in multiple ways to include: 1) the percentage of individuals on lists who respond and 2) the percentage of eligible respondents who enroll. Enrolled participants will be classified by recruitment method according to participant self-report of how they heard about the study,. Representativeness will be assessed by comparing demographics (age/grade, sex, race/ethnicity, BMI where available) between enrolled participants and non-participants including 1) potential participants on recruitment lists and 2) those who are screened but do not enroll. In addition, the investigators will assess the impact of nurse engagement/leadership on participant reach and attendance. |
9 months
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Physical activity
Časové okno: Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
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Self-reported physical activity will be collected from the exercise vital sign. A subset of participants will have physical activity measured using a study-provided Garmin activity device, a consumer wearable that will automatically detect and track activity such as walking, running, and cycling. This device will measures steps. |
Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
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Child diet
Časové okno: Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
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Child diet will be parent reported using the Children's Eating Habits Questionnaire-Food Frequency Questionnaire section (CEHQ-FFQ). We are interested in the frequency of red foods ("junk" foods) and fruits/vegetables. A subset of participants will complete this more frequently beginning at 13 weeks. |
Baseline, 13 weeks, 14 weeks, 15 weeks, 16 weeks/4 months, 18 weeks/5 months, 6 months, 7 months, 8 months, 9 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Spolupracovníci
Spolupracovníci
Vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Ann M Davis, PhD, MPH, ABPP, University of Kansas Medical Center
- Vrchní vyšetřovatel: Christie Befort, PhD, University of Kansas Medical Center
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- STUDY00147611
- R01NR019810 (Grant/smlouva NIH USA)
Informace o lécích a zařízeních, studijní dokumenty
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