- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
California
-
La Jolla, California, Förenta staterna, 93093
- University of California San Diego
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Weight change
Tidsram: 16 weeks
|
Change in weight from baseline to post-intervention (16 weeks).
|
16 weeks
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Anthropometrics
Tidsram: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Blood pressure
Tidsram: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Communication
Tidsram: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Relationship factors (dyad, family, social networks)
Tidsram: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Psychosocial factors
Tidsram: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Eating behavior
Tidsram: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Physical activity
Tidsram: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Weight control behavior
Tidsram: baseline and post-intervention (16 weeks)
|
baseline and post-intervention (16 weeks)
|
|
Treatment attendance and adherence
Tidsram: between baseline and post-intervention (16 weeks)
|
between baseline and post-intervention (16 weeks)
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 151345
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