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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Behavioral: Lifestyle Intervention

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Luis Obispo, California, United States, 93401
      • Cal Poly

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care
Experimental: Lifestyle Intervention	Behavioral: Lifestyle Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Partner's weight loss	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.	study entry, when pregnant partner reaches 35 weeks gestation

Collaborators and Investigators

• Sponsor: California Polytechnic State University-San Luis Obispo
• Collaborators: Dignity Health- French Hospital Medical Center
• Investigators: Principal Investigator: Suzanne Phelan, PhD, Cal Poly

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: July 30, 2014
• First Posted (Estimate): July 31, 2014

Study Record Updates

• Last Update Posted (Actual): August 28, 2020
• Last Update Submitted That Met QC Criteria: August 27, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Pregnancy; Overweight; Obese; Weight Loss; Weight Gain
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 72514