NCT01092364

Brief Summary

Weight gain accelerates during early adulthood, and leads to the health consequences of obesity (high blood pressure, diabetes, heart disease, etc). Most weight loss studies enroll middle-aged adults. This study tests the hypothesis that a weight loss intervention that builds on prior research evidence but is enhanced with technological innovations will lead to weight loss in a diverse group of overweight and obese adults aged 18-35 years. The technology intervention, using cell phone applications, will be compared to an "advice only" control group and to a group receiving a more traditional personal coaching intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
365

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable obesity

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

March 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2010

Completed
7 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

November 13, 2017

Completed
Last Updated

November 13, 2017

Status Verified

November 1, 2017

Enrollment Period

3.9 years

First QC Date

March 23, 2010

Results QC Date

August 21, 2017

Last Update Submit

November 1, 2017

Conditions

Keywords

Young adults

Outcome Measures

Primary Outcomes (1)

  • Change in Body Weight

    Baseline and 24 months

Study Arms (3)

Cell phone intervention

EXPERIMENTAL

Behavioral lifestyle intervention for weight loss, delivered by cell phone.

Behavioral: Behavioral weight loss intervention

Personal counseling intervention

EXPERIMENTAL

Behavioral lifestyle intervention for weight loss, delivered by personal counseling.

Behavioral: Behavioral weight loss intervention

Advice only

NO INTERVENTION

Advice only control group.

Interventions

Behavioral lifestyle intervention for weight loss, compared to advice-only control.

Cell phone interventionPersonal counseling intervention

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-35 years;
  • BMI \>=25;
  • Using a cellphone.

You may not qualify if:

  • Diabetes mellitus;
  • Pregnant or nursing;
  • Use of weight loss medications, systemic steroids, antipsychotics, or diabetes medication;
  • Prior weight loss surgery;
  • Cardiovascular (CVD) event in past 6 months;
  • Current malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (5)

  • Batch BC, Tyson C, Bagwell J, Corsino L, Intille S, Lin PH, Lazenka T, Bennett G, Bosworth HB, Voils C, Grambow S, Sutton A, Bordogna R, Pangborn M, Schwager J, Pilewski K, Caccia C, Burroughs J, Svetkey LP. Weight loss intervention for young adults using mobile technology: design and rationale of a randomized controlled trial - Cell Phone Intervention for You (CITY). Contemp Clin Trials. 2014 Mar;37(2):333-41. doi: 10.1016/j.cct.2014.01.003. Epub 2014 Jan 21.

    PMID: 24462568BACKGROUND
  • Svetkey LP, Batch BC, Lin PH, Intille SS, Corsino L, Tyson CC, Bosworth HB, Grambow SC, Voils C, Loria C, Gallis JA, Schwager J, Bennett GG. Cell phone intervention for you (CITY): A randomized, controlled trial of behavioral weight loss intervention for young adults using mobile technology. Obesity (Silver Spring). 2015 Nov;23(11):2133-41. doi: 10.1002/oby.21226.

    PMID: 26530929BACKGROUND
  • Lin PH, Intille S, Bennett G, Bosworth HB, Corsino L, Voils C, Grambow S, Lazenka T, Batch BC, Tyson C, Svetkey LP. Adaptive intervention design in mobile health: Intervention design and development in the Cell Phone Intervention for You trial. Clin Trials. 2015 Dec;12(6):634-45. doi: 10.1177/1740774515597222. Epub 2015 Jul 30.

    PMID: 26229119BACKGROUND
  • Metzendorf MI, Wieland LS, Richter B. Mobile health (m-health) smartphone interventions for adolescents and adults with overweight or obesity. Cochrane Database Syst Rev. 2024 Feb 20;2(2):CD013591. doi: 10.1002/14651858.CD013591.pub2.

  • Lin PH, Grambow S, Intille S, Gallis JA, Lazenka T, Bosworth H, Voils CL, Bennett GG, Batch B, Allen J, Corsino L, Tyson C, Svetkey L. The Association Between Engagement and Weight Loss Through Personal Coaching and Cell Phone Interventions in Young Adults: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2018 Oct 18;6(10):e10471. doi: 10.2196/10471.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr. Laura P. Svetkey
Organization
Duke University Medical Center

Study Officials

  • Laura P Svetkey, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 24, 2010

Study Start

November 1, 2010

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

November 13, 2017

Results First Posted

November 13, 2017

Record last verified: 2017-11

Locations