- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01770028
Ripple Effect of Lifestyle Intervention During Pregnancy on Partners' Weight
8. februar 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret 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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
122
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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California
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San Luis Obispo, California, Forenede Stater, 93407
- California Polytechnic State University
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New York
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New York, New York, Forenede Stater, 10027
- Columbia University
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02906
- Miriam Hospital
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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
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13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
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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
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Change in sleep patterns and sleep hours
Tidsramme: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
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13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
|
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Change in self-monitoring
Tidsramme: 13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum
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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
|
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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
|
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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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Todd A Hagobian, PhD, California Polytechnic State University-San Luis Obispo
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2013
Primær færdiggørelse (Faktiske)
1. juli 2017
Studieafslutning (Faktiske)
1. juli 2017
Datoer for studieregistrering
Først indsendt
8. januar 2013
Først indsendt, der opfyldte QC-kriterier
15. januar 2013
Først opslået (Skøn)
17. januar 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. februar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. februar 2018
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1R01HL118208 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .