- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01770028
Ripple Effect of Lifestyle Intervention During Pregnancy on Partners' Weight
8. februar 2018 oppdatert av: Todd Hagobian, California Polytechnic State University-San Luis Obispo
The primary aim of the proposed study is to determine whether lifestyle interventions to prevent excessive gestational weight gain in overweight/obese pregnant women have positive "ripple" effects on untreated partners in the home.
We hypothesize that partners of pregnant women randomized to the lifestyle intervention, relative to those of standard care, will have greater weight losses through 12-months.
Secondary aims examine partner improvements in weight control behaviors, the home environment, and psychosocial parameters.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
Lifestyle interventions targeting overweight individuals can produce positive "ripple" effects on untreated overweight partners in the home.
Interestingly, ripple effects on partners' weight appear most pronounced when the interventions target women.
Women, and mothers in particular, remain the primary "nutritional gatekeepers" of the home.
Despite widespread recognition that motherhood is a powerful motivator for behavior changes, no study to date has examined the "ripple" effects of prenatal lifestyle interventions that target mothers' gestational weight gain.
The primary aim of the proposed study is to determine whether lifestyle interventions to prevent excessive gestational weight gain in overweight/obese pregnant women have positive "ripple" effects on untreated partners in the home.
The proposed study is ancillary to two randomized phase III clinical trials in the LIFE-moms consortium (1U01HL114377-01, PI Phelan; 3U01DK094463-03S1, PIs Pi-Sunyer and Gallagher) that are examining the efficacy of multi-component lifestyle interventions to prevent excessive gestational weight gain in a total of 650 overweight/obese women.
In this ancillary study, partners' weight, home environment, and psychosocial behaviors will be assessed when their pregnant partners are ~13 weeks gestation (study entry), 35 weeks gestation and at 6 and 12 months postpartum.
We hypothesize that partners of pregnant women randomized to the lifestyle intervention, relative to those of standard care, will have greater weight losses through 12-months.
Secondary aims examine partner improvements in weight control behaviors, the home environment, and psychosocial parameters.
This project is highly innovative, as it capitalizes on existing funded research and is the first study to examine ripple effects of multicomponent prenatal interventions.
The project also has high impact, as pregnancy is a powerful motivator for behavior and environmental changes in the home; and, if positive ripple effects occur, the field of obesity treatment and prevention could move beyond focus on individual level to the often unrecognized interpersonal effects of lifestyle interventions.
PUBLIC HEALTH RELEVANCE: This research project will examine whether interventions to prevent excessive gestational weight gain have positive "ripple" effects on the health of untreated partners in the home.
Studietype
Observasjonsmessig
Registrering (Faktiske)
122
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
San Luis Obispo, California, Forente stater, 93407
- California Polytechnic State University
-
-
New York
-
New York, New York, Forente stater, 10027
- Columbia University
-
-
Rhode Island
-
Providence, Rhode Island, Forente stater, 02906
- Miriam Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
This study uses a randomized repeated measures design.
Partners will be categorized based on randomized status of their pregnant partner (in the parent grants; NIH 1U01HL114377-01, PI Phelan; NIH 3U01DK094418-01S1, PIs Redman and Martin).
Partner participation in the ancillary study will not be mandatory for participation in the parent grant.
NOTE: There is no intervention in partners.
Beskrivelse
Inclusion Criteria:
- Man or woman who self-identifies as sharing an intimate relationship and cohabitating in the home with the pregnant women (enrolled in the parent grant) for the previous 3 months or recently been married and living in the home
- ≥18 years
- willing to provide informed consent/assent
Exclusion Criteria:
- None
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
Intervention partners
Partners of pregnant women randomized to lifestyle intervention.
Note: There is no intervention in partners of pregnant women.
|
|
Standard care partners
Partners of pregnant women randomized to Standard Care.
Note: There is no intervention in partners of pregnant women.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in weight of partners of pregnant women
Tidsramme: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
Change in weight of partners of pregnant women randomized to the lifestyle intervention, relative to partners of pregnant women of standard care, from 13 weeks gestation to 35 weeks gestation and 6 and 12-months postpartum.
|
13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percent of partners with weight change loss >5%, 10%, and 15%
Tidsramme: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
|
Change in calorie and fat intake
Tidsramme: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
|
Change in physical activity levels
Tidsramme: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
|
Change in sleep patterns and sleep hours
Tidsramme: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
|
Change in self-monitoring
Tidsramme: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
|
Change in food, exercise and sedentary cues in the home environment
Tidsramme: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
|
Change in mood
Tidsramme: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
|
Change in dietary restraint
Tidsramme: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Todd A Hagobian, PhD, California Polytechnic State University-San Luis Obispo
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2013
Primær fullføring (Faktiske)
1. juli 2017
Studiet fullført (Faktiske)
1. juli 2017
Datoer for studieregistrering
Først innsendt
8. januar 2013
Først innsendt som oppfylte QC-kriteriene
15. januar 2013
Først lagt ut (Anslag)
17. januar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. februar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. februar 2018
Sist bekreftet
1. februar 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1R01HL118208 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .