Partners in Health: A Couples-based Approach to Obesity Prevention

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Behavioral: Lifestyle Intervention

• Registration Number: NCT02205281
• Lead Sponsor: California Polytechnic State University-San Luis Obispo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-30
• Study First Posted: 2014-07-31
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-27
• Last Update Posted: 2020-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Pregnant Women

• >18 years old
• 15-22 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

Exclusion Criteria

• Untreated medical or psychological problem
• Inability to be physically active

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lifestyle Intervention	Lifestyle Intervention	-

Primary Outcome Measures

Name	Time	Method
Gestational weight gain	16 weeks gestation, 35 weeks gestation	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.

Secondary Outcome Measures

Name	Time	Method
Partner's weight loss	study entry, when pregnant partner reaches 35 weeks gestation	Weight lost by the non-pregnant partner during the study will be assessed by subtracting their weight at the 35 week gestation visit from their study entry weight.

Trial Locations

Locations (1)

Cal Poly; 🇺🇸 San Luis Obispo, California, United States