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Completed

NCT Number: NCT02205281

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.

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Key information

Conditions

Obesity Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cal Poly

San Luis Obispo, California, 93401, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

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.

Primary outcomes

  1. Gestational weight gain

    Time frame: 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 outcomes

  1. Partner's weight loss

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

California Polytechnic State University-San Luis Obispo

Other

Collaborators

  • Dignity Health- French Hospital Medical Center

Registry information

Official study title

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

Acronym: PIH

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 31, 2014
Registry last updated
Aug 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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