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OpenTrials
Completed

NCT Number: NCT01491906

Weight Loss Among Adults in Beijing, China

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.

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Key information

Age range

35 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University

Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text Messaging and Behavior Counseling

Behavioral

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 outcomes

  1. Weight in kg

    Time frame: baseline and 6-months

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

Secondary outcomes

  1. Change in body composition & behavior

    Time frame: baseline and 6-months

    Secondary outcomes include change in blood pressure, weight circumference, dietary intake, physical activity, and psychosocial mediators at 6 months post-baseline

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • The George Institute for Global Health, China

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Dec 14, 2011
Registry last updated
Jul 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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