NCT01578512

Brief Summary

The purpose of this study is to determine the best format for delivering a brief behavioral weight loss intervention to young adults 18-25 years of age.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Feb 2012

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

April 17, 2012

Status Verified

March 1, 2012

Enrollment Period

6 months

First QC Date

April 12, 2012

Last Update Submit

April 16, 2012

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Weight

    2 months (post-treatment)

Study Arms (3)

Face-to-Face

EXPERIMENTAL

8 sessions of weekly group behavioral weight loss treatment

Behavioral: Face-to-Face

Web-based

EXPERIMENTAL

Participants receive one group face-to-face session followed by 7 web-based lessons, reporting of key behaviors, and feedback on progress.

Behavioral: Web-based

Single Session

ACTIVE COMPARATOR

Single session behavioral weight loss

Behavioral: Single session

Interventions

Face-to-FaceBEHAVIORAL

Face-to-Face behavioral weight loss

Face-to-Face
Web-basedBEHAVIORAL

Web-based behavioral weight loss

Web-based
Single sessionBEHAVIORAL

The core of behavioral weight loss, including calorie and activity prescriptions, are delivered in a single group treatment session.

Single Session

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • body mass index 25-45
  • willing to be randomly assigned to any of the 3 arms
  • available during the time frame of the study
  • willing to complete assessment visits at 0, 2, 4 and 6 months

You may not qualify if:

  • Age or BMI outside of eligible range
  • Medical condition that would interfere with weight loss or make unsupervised physical activity unsafe
  • Pregnant or nursing within 6 months
  • recent weight loss \>10% of body weight
  • History of eating disorder
  • Substance abuse or dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weight Control and Diabetes Research Center, the Miriam Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jessica LaRose, PhD

CONTACT

401-793-8283jessica_gokee_larose@brown.edu

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

April 12, 2012

First Posted

April 17, 2012

Study Start

February 1, 2012

Primary Completion

August 1, 2012

Study Completion

November 1, 2012

Last Updated

April 17, 2012

Record last verified: 2012-03

Locations

US(1)