NCT01770028

Brief Summary

The primary aim of the proposed study is to determine whether lifestyle interventions to prevent excessive gestational weight gain in overweight/obese pregnant women have positive "ripple" effects on untreated partners in the home. We hypothesize that partners of pregnant women randomized to the lifestyle intervention, relative to those of standard care, will have greater weight losses through 12-months. Secondary aims examine partner improvements in weight control behaviors, the home environment, and psychosocial parameters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2013

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 12, 2018

Status Verified

February 1, 2018

Enrollment Period

4.5 years

First QC Date

January 8, 2013

Last Update Submit

February 8, 2018

Conditions

Obesity

Keywords

ObesityPregnancySpouseWeight lossBehavioral

Outcome Measures

Primary Outcomes (1)

  • Change in weight of partners of pregnant women

    Change in weight of partners of pregnant women randomized to the lifestyle intervention, relative to partners of pregnant women of standard care, from 13 weeks gestation to 35 weeks gestation and 6 and 12-months postpartum.

    13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum

Secondary Outcomes (8)

  • Percent of partners with weight change loss >5%, 10%, and 15%

    13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum

  • Change in calorie and fat intake

    13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum

  • Change in physical activity levels

    13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum

  • Change in sleep patterns and sleep hours

    13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum

  • Change in self-monitoring

    13 weeks gestation, 35 weeks gestation, 6 months and 12 months postpartum

  • +3 more secondary outcomes

Study Arms (2)

Intervention partners

Partners of pregnant women randomized to lifestyle intervention. Note: There is no intervention in partners of pregnant women.

Standard care partners

Partners of pregnant women randomized to Standard Care. Note: There is no intervention in partners of pregnant women.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study uses a randomized repeated measures design. Partners will be categorized based on randomized status of their pregnant partner (in the parent grants; NIH 1U01HL114377-01, PI Phelan; NIH 3U01DK094418-01S1, PIs Redman and Martin). Partner participation in the ancillary study will not be mandatory for participation in the parent grant. NOTE: There is no intervention in partners.

You may qualify if:

  • Man or woman who self-identifies as sharing an intimate relationship and cohabitating in the home with the pregnant women (enrolled in the parent grant) for the previous 3 months or recently been married and living in the home
  • ≥18 years
  • willing to provide informed consent/assent

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

California Polytechnic State University

San Luis Obispo, California, 93407, United States

Location

Columbia University

New York, New York, 10027, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (1)

  • Hagobian TA, Phelan S, Schaffner A, Brannen A, McHugh A, Ashby-Thompson M, Gorin AA, Pi-Sunyer X, Gallagher D, Wing R. Ripple Effect of Lifestyle Interventions During Pregnancy on Untreated Partners' Weight. Obesity (Silver Spring). 2019 May;27(5):733-739. doi: 10.1002/oby.22447. Epub 2019 Apr 8.

    PMID: 30957985DERIVED

MeSH Terms

Conditions

ObesityWeight LossBehavior

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Todd A Hagobian, PhD

    California Polytechnic State University-San Luis Obispo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
19 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 17, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

February 12, 2018

Record last verified: 2018-02

Locations

US(3)