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Weight Loss Among Adults in Beijing, China

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The George Institute for Global Health, China
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01491906
First received: December 6, 2011
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Obesity
Hypertension
 Behavioral: Text Messaging and Behavior Counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weight Loss Among Adults in Beijing, China

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Weight in kg [ Time Frame: baseline and 6-months ] [ Designated as safety issue: No ]
    Weight measurements will be taken at baseline and at the 6-month follow-up visit


Secondary Outcome Measures:
  • Change in body composition & behavior [ Time Frame: baseline and 6-months ] [ Designated as safety issue: No ]
    Secondary outcomes include change in blood pressure, weight circumference, dietary intake, physical activity, and psychosocial mediators at 6 months post-baseline


Enrollment: 123
Study Start Date: May 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Text-Messaging
The group that receives the behavioral counseling and text messaging lifestyle intervention
 Behavioral: Text Messaging and Behavior Counseling
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.
No Intervention: Usual Care
This group will receive usual care

Detailed Description:

The rapid gains in China's economic development during the past two decades have been accompanied by similar gains in the population's waistline. Over 25% of Chinese adult females and more than a third of males are overweight or obese and rates are highest in urban areas such as Beijing. By 2015, overweight/obesity prevalence in China may reach 50% , thus imposing a heavy toll on chronic disease rates and health care costs. Despite these pressing public health challenges, very few obesity intervention studies have been conducted among Chinese adults.

Duke University and Peking University have partnered to implement an intervention to address these rapid changes in weight. 124 participants in Beijing will be randomly assigned to either: (1) usual care (UC), or; (2) a 6-month weight loss (WL) intervention condition. The primary outcome is weight change (kg) at 6 months post-baseline. Secondary outcomes include change in blood pressure, weight circumference, dietary intake, physical activity, and psychosocial mediators at 6 months post-baseline.

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. These are evidence-based approaches, drawn from the investigators' collective research experience.

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491906

Locations
China
Peking University
Beijing, China
Sponsors and Collaborators
Duke University
The George Institute for Global Health, China
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01491906     History of Changes
Other Study ID Numbers: A0458
Study First Received: December 6, 2011
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board
China: PKU Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Obesity
Weight Loss
Vascular Diseases
Cardiovascular Diseases
Overnutrition
 Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 23, 2013