Partners in Health: A Couples-based Approach to Obesity Prevention
PIH
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this pilot study is to test the feasibility of an innovative, couples based approach to weight management during pregnancy. The primary hypothesis is that a couples-based behavioral weight management program will reduce the rate of gestational weight gain compared to standard care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jun 2014
Longer than P75 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 29, 2014
CompletedFirst Posted
Study publicly available on registry
July 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedAugust 28, 2020
August 1, 2020
3.9 years
July 29, 2014
August 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gestational weight gain
Rate of gestational weight gain will be computed as difference between weights measured at study entry and gestational week 35; this difference will be divided by the number of weeks of observation during pregnancy (i.e., weeks between study entry and final pregnancy assessment). If gestational week 35 is unavailable, most proximal clinic visit weight will be used.
16 weeks gestation, 35 weeks gestation
Secondary Outcomes (1)
Partner's weight loss
study entry, when pregnant partner reaches 35 weeks gestation
Study Arms (2)
Standard Care
NO INTERVENTIONLifestyle Intervention
EXPERIMENTALInterventions
The intervention is a multi-component program designed to prevent excessive gestational weight gain in overweight and obese women and to promote weight loss in their non-pregnant overweight and obese partners through modifications of diet, exercise, and behavioral strategies during pregnancy.
Eligibility Criteria
You may qualify if:
- Pregnant Women
- \>18 years old
- weeks gestation
- BMI \>= 25
- cohabitating with partner for at least 3 months or recently married
- willing to consent
- Non-pregnant Partner
- BMI \>= 25
- cohabitating with partner for at least 3 months or recently married
- willing to consent
You may not qualify if:
- Untreated medical or psychological problem
- Inability to be physically active
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cal Poly
San Luis Obispo, California, 93401, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne Phelan, PhD
Cal Poly
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 29, 2014
First Posted
July 31, 2014
Study Start
June 1, 2014
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
August 28, 2020
Record last verified: 2020-08