ObesityNCT01491906
Weight Loss Among Adults in Beijing, China
A study testing Text Messaging and Behavior Counseling in people with Obesity and Hypertension, run by Duke University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hypertension
- What is being tested?
- Text Messaging and Behavior Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteChina
- Study dates
- May 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI ≥ 24,
- age 30-55 years
- current use of a mobile phone
- interest in losing weight.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity, Hypertension
- Being tested
- Text Messaging and Behavior Counseling
- Medical subject headings
- Obesity, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Messaging and Behavior CounselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Text-Messaging | Experimental | The group that receives the behavioral counseling and text messaging lifestyle intervention Receives: Behavioral: Text Messaging and Behavior Counseling |
| Usual Care | No intervention | This group will receive usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight in kg
Weight measurements will be taken at baseline and at the 6-month follow-up visit
Measured: baseline and 6-months
Secondary outcomes (1)
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
Measured: baseline and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- The George Institute for Global Health, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491906
- Sponsor's protocol ID
- A0458
- Status last verified
- Jul 2014
- First submitted
- 6 Dec 2011
- Last updated
- 29 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24375969
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Among Adults in Beijing, China
- ClinicalTrials.gov ID
- NCT01491906
- Acronym / sponsor ID
- A0458
- Conditions
- Obesity, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- The George Institute for Global Health, China
- Study start
- May 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Text-Messaging | Experimental | Behavioral: Text Messaging and Behavior CounselingThe group that receives the behavioral counseling and text messaging lifestyle intervention |
| Usual Care | No intervention | –This group will receive usual care |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI ≥ 24,
- age 30-55 years
- current use of a mobile phone
- interest in losing weight.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text Messaging and Behavior CounselingParticipants 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. | Behavioural | Text-Messaging |
Primary outcome
Weight in kg
Time frame: baseline and 6-months
Weight measurements will be taken at baseline and at the 6-month follow-up visit
1 secondary outcome
Change in body composition & behavior
Time frame: baseline and 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2014.
- Results publication: PubMed 24375969Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messaging and Behavior Counseling in people with Obesity and Hypertension, run by Duke University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight in kg (time frame: baseline and 6-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01491906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2014.