NCT01921959

Brief Summary

The purpose of this ancillary study is to determine whether a behavioral weight loss intervention for postpartum mothers (5R01DK087889-02, PI Phelan; Co-I Tate) has a positive "ripple" effect on weight and health of partners and children/offspring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 14, 2013

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

February 13, 2018

Status Verified

February 1, 2018

Enrollment Period

4 years

First QC Date

August 9, 2013

Last Update Submit

February 12, 2018

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Weight and Weight Change

    Absolute weight and change in weight

    12 months

Study Arms (2)

Partners of intervention women

Partners of women randomized to intervention

Behavioral: Intervention

Partners of no intervention women

Partners of women randomized to control

Interventions

InterventionBEHAVIORAL

Postpartum women are randomized to intervention or control group

Partners of intervention women

Eligibility Criteria

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

Partners of postpartum women

You may qualify if:

  • Man or woman who self-identifies as sharing an intimate relationship and cohabitating in the home with the postpartum woman (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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

California Polytechnic State University

San Luis Obispo, California, 93407, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Todd Hagobian, PhD

    Cal Poly San Luis Obispo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 9, 2013

First Posted

August 14, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

February 13, 2018

Record last verified: 2018-02

Locations

US(1)