NCT03042208

Brief Summary

Research suggests that when one spouse loses weight, the other spouse does too. This study will examine whether a ripple effect is observed in untreated spouses and children of individuals participating in a nationally available weight loss program. Participants will be randomly assigned to either receive Weight Watchers immediately or at the end of a 6-month waiting period. Participants and untreated spouses (and any children in the home) will be assessed at baseline, 3, and 6 months.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

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

January 2, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
Last Updated

February 3, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

January 31, 2017

Last Update Submit

February 1, 2017

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • Change in Weight

    body weight measured in kg

    0, 3, and 6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Access to Weight Watchers in-person meetings and online tools.

Behavioral: Weight Watchers

Self-Guided Control Group

OTHER

Received handout with basic weight management advice.

Other: Self guided handout

Interventions

Self guided handoutOTHER

Written handout with basic weight management strategies

Self-Guided Control Group
Weight WatchersBEHAVIORAL

Access to Weight Watchers in-person meetings and online tools

Intervention

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • body mass index between 27.0-40.0 kg/m2
  • married or living with a significant other who had a BMI \> 25 kg/m2

You may not qualify if:

  • currently in a weight loss program, dieting, or taking medications that might affect weight
  • had participated in a weight loss program in the past year
  • lost \> 5% of their body weight in the past 6 months
  • were planning to or had undergone weight loss surgery
  • had any orthopedic limitations or contraindications to physical activity
  • were pregnant, lactating, or less than 6 months postpartum, or were planning to become pregnant in the next year
  • reported uncontrolled hypertension, history of coronary heart disease, stroke, or peripheral arterial disease; reported chronic gastrointestinal disease
  • endorsed having hepatitis B or C, cirrhosis, or HIV
  • had a history of cancer within the past 5 years
  • reported a significant psychiatric illness that might interfere with completion of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • McManus-Shipp KE, Cornelius T, Wojtanowski AC, Leahey T, Foster GD, Gorin AA. Family functioning and the implications for adult weight management. Fam Syst Health. 2025 Mar;43(1):157-161. doi: 10.1037/fsh0000929. Epub 2024 Sep 16.

    PMID: 39283252DERIVED

  • Gorin AA, Lenz EM, Cornelius T, Huedo-Medina T, Wojtanowski AC, Foster GD. Randomized Controlled Trial Examining the Ripple Effect of a Nationally Available Weight Management Program on Untreated Spouses. Obesity (Silver Spring). 2018 Mar;26(3):499-504. doi: 10.1002/oby.22098. Epub 2018 Feb 1.

    PMID: 29388385DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2017

First Posted

February 3, 2017

Study Start

January 2, 2015

Primary Completion

October 30, 2015

Study Completion

October 30, 2015

Last Updated

February 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share