- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02787902
Weight Management in Mothers and Adult Daughters
Improving Communication and Collaboration for Weight Management in Mother-daughter
The purpose of this study is to develop, implement, and evaluate a behavioral weight management intervention with a communication training component for Mexican-American women. The study has three specific aims.
Aim 1: Develop a behavioral weight loss intervention that modifies evidence-based behavioral weight loss treatment using results from formative data collected from Mexican-American mother-daughter dyads. The adapted intervention will focus on improving dyadic communication and collaboration for providing reciprocal support for healthy eating and physical activity behaviors.
Aim 2: Implement and evaluate a pilot weight management program adapted for mother-daughter dyads. Dyads will be randomly assigned to partner-based treatment with or without communication skills training.
Aim 3: Evaluate associations between changes in weight, weight-related behaviors, and psychosocial variables with changes in measures assessing interpersonal communication.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
-
La Jolla, California, Forenede Stater, 93093
- University of California San Diego
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Female
- Body mass index of 25-50 kg/m2
- Mexican or Mexican-American
Exclusion Criteria:
- Pregnancy or plans to become pregnant in the next year
- 5% weight loss in the last 3 months
- History of bariatric surgery
- Serious medical condition or psychological disorder
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Communication
Behavioral weight loss program with communication skills training
|
Behavioral weight management program adapted for mother-daughter dyads with communication skills training
|
|
Aktiv komparator: Standard
Standard behavioral weight loss program
|
Behavioral weight management program adapted for mother-daughter dyads without communication skills training
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Weight change
Tidsramme: 16 weeks
|
Change in weight from baseline to post-intervention (16 weeks).
|
16 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Anthropometrics
Tidsramme: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Blood pressure
Tidsramme: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Communication
Tidsramme: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Relationship factors (dyad, family, social networks)
Tidsramme: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Psychosocial factors
Tidsramme: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Eating behavior
Tidsramme: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Physical activity
Tidsramme: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Weight control behavior
Tidsramme: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Treatment attendance and adherence
Tidsramme: between baseline and post-intervention (16 weeks)
|
between baseline and post-intervention (16 weeks)
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 151345
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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