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

NCT ID: NCT02205281

Last Updated: 2020-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-05-31

Brief Summary

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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

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Care

Group Type NO_INTERVENTION

No interventions assigned to this group

Lifestyle Intervention

Group Type EXPERIMENTAL

Lifestyle Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Dignity Health- French Hospital Medical Center

UNKNOWN

Sponsor Role collaborator

California Polytechnic State University-San Luis Obispo

OTHER

Sponsor Role lead

Responsible Party

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Suzanne Phelan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzanne Phelan, PhD

Role: PRINCIPAL_INVESTIGATOR

Cal Poly

Locations

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Cal Poly

San Luis Obispo, California, United States

Site Status

Countries

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United States

Other Identifiers

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72514

Identifier Type: -

Identifier Source: org_study_id

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