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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Intervention
Sponsored by
California Polytechnic State University-San Luis Obispo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Overweight, Obese, Pregnancy, Weight Gain, Weight Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cal Poly

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Lifestyle Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 29, 2014
Last Updated
August 27, 2020
Sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
Dignity Health- French Hospital Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02205281
Brief Title
Partners in Health: A Couples-based Approach to Obesity Prevention
Acronym
PIH
Official Title
Partners in Health: A Couples-based Approach to Obesity Prevention.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Polytechnic State University-San Luis Obispo
Collaborators
Dignity Health- French Hospital Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Overweight, Obese, Pregnancy, Weight Gain, Weight Loss

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Title
Lifestyle Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gestational weight gain
Description
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.
Time Frame
16 weeks gestation, 35 weeks gestation
Secondary Outcome Measure Information:
Title
Partner's weight loss
Description
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.
Time Frame
study entry, when pregnant partner reaches 35 weeks gestation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Phelan, PhD
Organizational Affiliation
Cal Poly
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cal Poly
City
San Luis Obispo
State/Province
California
ZIP/Postal Code
93401
Country
United States

12. IPD Sharing Statement

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

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