NCT03037567

Brief Summary

The purpose of this study is to examine the acceptability and efficacy of a modified Weight Watchers program over 24 weeks. Assessments will be conducted at 0, 3, and 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 27, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

January 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

May 18, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

January 27, 2017

Last Update Submit

May 17, 2018

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • Weight Change

    Mean Change in body weight (kg) Body weight will be assessed on a calibrated digital scale and recorded to the nearest 0.1 kg.

    0 - 6 months

Secondary Outcomes (6)

  • Achieving a weight loss of 5% or more

    0 - 6 months

  • Achieving a weight loss of 5% or more

    0 - 3 months

  • Weight Change

    0 - 3 months

  • Waist circumference change (cm) (mean)

    0 - 3 months

  • Waist circumference change (cm) (mean)

    0 - 6 months

  • +1 more secondary outcomes

Study Arms (1)

Modified Weight Watchers plan

EXPERIMENTAL

Modified Weight Watchers Plan which includes a food plan, activity plan, group support and cognitive behavior modification. Weekly study-specific group meetings; electronic tools through iPhone app for 24 weeks.

Behavioral: Modified Weight Watchers plan

Interventions

Modified Weight Watchers planBEHAVIORAL

Weight Watchers is a structured lifestyle modification program that includes a food plan based on balanced diet and healthy eating, activity plan designed to promote progressive physical activity increase, group support and cognitive behavior modification. Participants attend weekly in-person group meetings led by a trained Weight Watchers meeting leader and have a suite of electronic tools available through an iPhone app.

Modified Weight Watchers plan

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) between 25 and 43 kg/m²
  • Ability to read and speak English
  • All ethnic groups will be recruited
  • Self-report desire to lose weight and willing to follow study recommendations
  • Use of an iPhone with iOS 8.0 or later for use on a daily basis, and basic app skills
  • Have access to the internet via a computer, and basic computer skills

You may not qualify if:

  • Currently following a commercial weight-loss program (including Weight Watchers) or who followed a weight loss program in the previous 6 months or who were members of Weight Watchers within the past 12 months
  • Another member of the household participating in the study.
  • Pregnant or nursing, or planning on becoming pregnant over the next 9 months.
  • Planning to relocate in the next 9 months
  • Involvement in another research study that would interfere with participation in this study
  • Excessive alcohol intake or dependence
  • Recent weight loss of ≥ 5 kg in the previous 6 months.
  • Report health problems that make weight loss or unsupervised exercise unsafe or unreasonable (e.g., orthopedic limitations, heart problems, history or heart attack or stroke)
  • History of clinically diagnosed eating disorder.
  • Untreated thyroid disease or and changes in dose or type of thyroid medication over previous 6 months
  • Chronic/inflammatory gastrointestinal disorders (Irritable Bowel Syndrome acceptable)
  • Taking any prescription medication with known effects on appetite or weight
  • Previous surgical procedure for weight loss.
  • Major surgery within the previous 6 months.
  • Resting systolic blood pressure \>160 mmHg or resting diastolic blood pressure \>100 mmHg
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Deborah F Tate, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2017

First Posted

January 31, 2017

Study Start

January 27, 2017

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

May 18, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)