NCT01491906

Brief Summary

The purpose of this study is to test the effect of a mobile phone-assisted lifestyle intervention on weight loss at 6 months among overweight/obese Chinese adults, as compared to a control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2011

Typical duration 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

Study Start

First participant enrolled

May 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

July 29, 2014

Status Verified

July 1, 2014

Enrollment Period

9 months

First QC Date

December 6, 2011

Last Update Submit

July 28, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Weight in kg

    Weight measurements will be taken at baseline and at the 6-month follow-up visit

    baseline and 6-months

Secondary Outcomes (1)

  • Change in body composition & behavior

    baseline and 6-months

Study Arms (2)

Text-Messaging

EXPERIMENTAL

The group that receives the behavioral counseling and text messaging lifestyle intervention

Behavioral: Text Messaging and Behavior Counseling

Usual Care

NO INTERVENTION

This group will receive usual care

Interventions

Participants randomized to the intervention arm will receive a series of components, delivered over 6 months: personalized behavior change goals to be self-monitored via text messaging, group "starter" counseling sessions, and personalized individual counseling. Each participant will also receive a pedometer to facilitate self-monitoring.

Text-Messaging

Eligibility Criteria

Age35 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI ≥ 24,
  • age 30-55 years
  • current use of a mobile phone
  • interest in losing weight.

You may not qualify if:

  • Pregnancy or plans to become pregnant within 10 months of recruitment
  • current lactation
  • occurrence of a major cardiovascular disease (e.g., myocardial infarction or stroke in the past 6 months)
  • other serious medical conditions that contraindicate weight loss (e.g., end-stage renal disease on dialysis, cancer diagnosis or treatment in past 2 years)
  • blood pressure ≥ 160/100 mm Hg
  • type 2 diabetes or controlled by lifestyle only
  • use of medications known to increase body weight
  • substance abuse; psychiatric illness, including major depression, which could interfere with study adherence
  • prior or planned bariatric surgery
  • use of weight loss medications or weight loss ≥ 5% of initial weight in past 6 months
  • plans to relocate in next 10 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University

Beijing, China

Location

Related Publications (1)

  • Lin PH, Wang Y, Levine E, Askew S, Lin S, Chang C, Sun J, Foley P, Wang H, Li X, Bennett GG. A text messaging-assisted randomized lifestyle weight loss clinical trial among overweight adults in Beijing. Obesity (Silver Spring). 2014 May;22(5):E29-37. doi: 10.1002/oby.20686. Epub 2014 Jan 9.

MeSH Terms

Conditions

ObesityHypertension

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2011

First Posted

December 14, 2011

Study Start

May 1, 2011

Primary Completion

February 1, 2012

Study Completion

June 1, 2014

Last Updated

July 29, 2014

Record last verified: 2014-07

Locations