SPARK a Healthy and Fit Lifestyle

NCT ID: NCT01578512

Last Updated: 2012-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Face-to-Face

8 sessions of weekly group behavioral weight loss treatment

Group Type EXPERIMENTAL

Face-to-Face

Intervention Type BEHAVIORAL

Face-to-Face behavioral weight loss

Web-based

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

Group Type EXPERIMENTAL

Web-based

Intervention Type BEHAVIORAL

Web-based behavioral weight loss

Single Session

Single session behavioral weight loss

Group Type ACTIVE_COMPARATOR

Single session

Intervention Type BEHAVIORAL

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

Interventions

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Face-to-Face

Face-to-Face behavioral weight loss

Intervention Type BEHAVIORAL

Web-based

Web-based behavioral weight loss

Intervention Type BEHAVIORAL

Single session

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18-25 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

The Miriam Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Weight Control and Diabetes Research Center, the Miriam Hospital

Providence, Rhode Island, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica LaRose, PhD

Role: CONTACT

401-793-8283

Facility Contacts

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Jessica LaRose, PhD

Role: primary

401-793-8283

Other Identifiers

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DK083440

Identifier Type: -

Identifier Source: org_study_id

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