Weight Loss Among Adults in Beijing, China
Primary Purpose
Obesity, Hypertension
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Text Messaging and Behavior Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility 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
Sites / Locations
- Peking University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Text-Messaging
Usual Care
Arm Description
The group that receives the behavioral counseling and text messaging lifestyle intervention
This group will receive usual care
Outcomes
Primary Outcome Measures
Weight in kg
Weight measurements will be taken at baseline and at the 6-month follow-up visit
Secondary Outcome Measures
Change in body composition & behavior
Secondary outcomes include change in blood pressure, weight circumference, dietary intake, physical activity, and psychosocial mediators at 6 months post-baseline
Full Information
NCT ID
NCT01491906
First Posted
December 6, 2011
Last Updated
July 28, 2014
Sponsor
Duke University
Collaborators
The George Institute for Global Health, China
1. Study Identification
Unique Protocol Identification Number
NCT01491906
Brief Title
Weight Loss Among Adults in Beijing, China
Official Title
Weight Loss Among Adults in Beijing, China
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
The George Institute for Global Health, China
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
123 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Text-Messaging
Arm Type
Experimental
Arm Description
The group that receives the behavioral counseling and text messaging lifestyle intervention
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
This group will receive usual care
Intervention Type
Behavioral
Intervention Name(s)
Text Messaging and Behavior Counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight in kg
Description
Weight measurements will be taken at baseline and at the 6-month follow-up visit
Time Frame
baseline and 6-months
Secondary Outcome Measure Information:
Title
Change in body composition & behavior
Description
Secondary outcomes include change in blood pressure, weight circumference, dietary intake, physical activity, and psychosocial mediators at 6 months post-baseline
Time Frame
baseline and 6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Peking University
City
Beijing
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
24375969
Citation
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.
Results Reference
result
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Weight Loss Among Adults in Beijing, China
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