Weight LossNCT06237933
A Social-networking-site(SNS) Based Weight Loss Behavior Intervention- the Effect of Social Network and Multi-level Factors on Weight Loss
A study testing Enhanced intervention via social networking site (SNS) and Standard intervention in people with Weight Loss, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In this project, investigators plan to conduct a randomized control trial of a weight loss intervention that is remotely delivered via SNS among the obese adult patients (20-64 years old, BMI ≥ 27 kg/m2) recruited from weight control clinic in a tertiary medical center in Taipei. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Weight Loss
- What is being tested?
- Enhanced intervention via social networking site (SNS) and Standard intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2017to 31 Jul 2020
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 20-64 years
- Body mass index (BMI) ≥27 kg/m2
- Used Facebook or were willing to begin, owned a personal computer or owned a smartphone, and are healthy enough and willing to attend this program with measurement visits in 2 years.
Who cannot join
- Pregnancy
- Previous diagnosis of diabetes mellitus
- History of psychosis, severe anxiety, major depression, panic, or Clinically diagnosed eating disorder
- History of surgical treatment for obesity
- Alcoholism or drug abuse.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial of a Social-networking-site(SNS) Based Weight Loss Behavior Intervention- the Effect of Social Network and Multi-level Factors on Weight Loss
In this project, investigators plan to conduct a randomized control trial of a weight loss intervention that is remotely delivered via SNS among the obese adult patients (20-64 years old, BMI ≥ 27 kg/m2) recruited from weight control clinic in a tertiary medical center in Taipei. Investigators will survey the participants' baseline characteristics at different dimensions including personal, behavioral, physiological, socio-environmental factors. Participants will be randomly assigned to a 16-week weight loss program of either enhanced intervention via Facebook group or standard intervention. After the intervention, the participants will be followed until 2 years after enrollment. Investigators will measure participants' change in weight as well as change in attitude, behavior, and physiological along the follow-up periods. Investigators proposed specific study aims as following: (1) Demonstrate the characteristics of the obese patient who visiting weight-control clinics at behavioral level, physiological level, and social level. (2) Implement an enhanced weight loss intervention by using SNS with personalized feedback (3) Investigate the social influence and the interaction between participants in the social networking site (4) Test the hypothesis that, compared with a standard behavioral weight loss intervention, the enhanced intervention would result in greater weight loss and physical benefit (5) Test the hypothesis that, the enhanced intervention would result in improvement on heath attitude, literacy, or behavior and minimize the attrition of weight loss program (6) Explore the trajectory of individual characteristics throughout the treatment course (7) Explore the predictor or correlate of successful weight loss, maintenance and attrition (8) Investigate the interrelationship between different behavioral, physiological, and environmental factors and their composite effect on weight loss (9) Refine the intervention and develop a further effective and individualized behavior intervention for weight loss
Read the detailed description
Obesity with its increasing prevalence has become a global health problem. Even modest weight loss induced by lifestyle intervention can produce clinically meaningful health benefits, however, most participants in the weight loss program fail in the longer term because of poor adherence and easy weight regain. An effective behavior therapy for weight loss is believed to have two core elements: (1) a convenient program focusing on individual response and variability, and (2) a better understanding of the predictors and correlates of weight loss outcome. Nowadays, the internet-based program featured with dynamic materials and personalized feedback has been utilized as a novel tool for weight loss. Besides, social networking site (SNS), such as Facebook, is a web-based platform for interaction. Increasing evidence demonstrated interventions through SNSs had substantial potentials on social influence and health behavior change. Research about the effectiveness of weight loss intervention via SNSs has gained much concern in recent years. Predictions of weight loss outcome based on personal characteristics are under investigation for several decades. Identifying predictors or correlates to weight loss outcome can help optimize the efficacy of the program through a better matching of intervention. Because weight loss is a is a dynamic and complex process encompassing interaction of behavioral, physiological and socio-environmental factors, a multi-factorial approach is required for research design. n this 3-year study project, investigators plan to conduct a pilot randomized control trial of a 2-year weight loss intervention that is remotely delivered via social networking site among the obese adult participants (20-64 years old, BMI ≥ 27 kg/m2) recruited from weight control clinic in medical center in Taipei, Taiwan. Investigators will survey the participants' baseline characteristics at different dimensions including personal, behavioral, physiological, social and environmental factors. Participants will be randomly assigned to a 16-week weight loss program of either enhanced intervention via Facebook or standard intervention. After the intervention, the participants will be followed for another 1 year and 8 months. The change in weight will be measured at 6 months, 12 months and 24 months after enrollment. Participants' change in attitude, behavior, and physiological condition will also be measured along the follow-up so that investigators can demonstrate the trajectory and interaction of different variables along the weight loss process. With this 3-year project, investigators not only assess the efficacy of this pilot weight loss program in Taiwan, but investigators also explore the possible predictors and correlates of successful weight loss.
- Conditions
- Weight Loss
- Being tested
- Enhanced intervention via social networking site (SNS), Standard intervention
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced intervention via social networking site (SNS)Behavioural
We plan to organize a private Facebook group serve as platform to provide the intervention content. To ensure confidentiality, this Facebook group is completely private and the group member is invited only by study staff. The participants of intervention group received information about the private Facebook group and privacy settings and were instructed to join the Facebook group. The intervention comprises three parts. Doctor patient interaction: The interventionist (physicians and dietitians) act as health coach will provide evidence-based topics related to weight loss on Facebook discussion board every two weeks
Standard interventionBehavioural
In the session, the participants are instructed by an interventionist to have a reduced calorie diet and regular physical activity. Calorie intake was prescribed based on baseline weight at 1200 kcal/d for individuals who weighed less than 90 kg, 1500 kcal/d for those who weighed 90 to less than 115 kg, and 1800 kcal/d for those who weighed 115kg or more. The interventionist will give each participants dietary recommendation and sample meal plans are provided to facilitate adoption. The interventionist will prescribe non-supervised moderate-to-vigorous physical activity to participants. Participants should start moderate-to-vigorous physical activity at 100 minutes per week and increased at 4-week intervals until a prescription of 300 minutes per week was achieved
| Study group | Role | What they receive |
|---|---|---|
| Enhanced intervention | Experimental | Enhanced intervention features of using social-networking-site site and personalized feedback, plus standard intervention Receives: Behavioral: Enhanced intervention via social networking site (SNS) |
| Control | Active comparator | Standard intervention with regular in-person consultation Receives: Behavioral: Standard intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight change
Weight in kilogram is assessed to the nearest 0.1 kg with the participant clothed in lightweight clothing. Weight change is calculated as weight after intervention minus weight at baseline. Weight change is calculated for each participant.
Measured: 4weeks, 8weeks, 13weeks, 26weeks, 52weeks, 78weeks, 104weeks
Secondary outcomes (3)
Participants' eating behavior
The questionnaire, three factor eating questionnaire-R18(TFEQ-R18), for assessment of participants' eating behavior. (The minimum score of TFEQ-R18 for eating behavior I(cognitive restraint of eating)-II(disinhibition)-III(hunger) is therefore 0-0-0, and maximum possible score is 20-16-15. Higher score means higher tendency of each eating behavior).
Measured: 26weeks, 52weeks, 78weeks, 104weeks
Participants' psychological distress
The questionnaire, Brief Symptom Rating Scale-5(BSRS-5) for assessment of participants' psychological distress. (The minimum score of BSRS-5 is 0 and maximum possible score is 20. Higher score means worse outcome, higher psychological distress.)
Measured: 26weeks, 52weeks, 78weeks, 104weeks
Participants' quality of life
The questionnaire, Clinical Impairment Assessment Questionnaire(CIA 3.0) for assessment of participants' quality of life. (The minimum score of CIA 3.0 is 0 and maximum possible score is 48. Higher score means worse outcome, poor quality of life.)
Measured: 26weeks, 52weeks, 78weeks, 104weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start1 Aug 2017
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06237933
- Sponsor's protocol ID
- 201612183RINB
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of a Social-networking-site(SNS) Based Weight Loss Behavior Intervention- the Effect of Social Network and Multi-level Factors on Weight Loss
- ClinicalTrials.gov ID
- NCT06237933
- Acronym / sponsor ID
- 201612183RINB
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 2 Feb 2024 (actual)
- 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.
In this project, investigators plan to conduct a randomized control trial of a weight loss intervention that is remotely delivered via SNS among the obese adult patients (20-64 years old, BMI ≥ 27 kg/m2) recruited from weight control clinic in a tertiary medical center in Taipei. Investigators will survey the participants' baseline characteristics at different dimensions including personal, behavioral, physiological, socio-environmental factors. Participants will be randomly assigned to a 16-week weight loss program of either enhanced intervention via Facebook group or standard intervention. After the intervention, the participants will be followed until 2 years after enrollment. Investigators will measure participants' change in weight as well as change in attitude, behavior, and physiological along the follow-up periods. Investigators proposed specific study aims as following: (1) Demonstrate the characteristics of the obese patient who visiting weight-control clinics at behavioral level, physiological level, and social level. (2) Implement an enhanced weight loss intervention by using SNS with personalized feedback (3) Investigate the social influence and the interaction between participants in the social networking site (4) Test the hypothesis that, compared with a standard behavioral weight loss intervention, the enhanced intervention would result in greater weight loss and physical benefit (5) Test the hypothesis that, the enhanced intervention would result in improvement on heath attitude, literacy, or behavior and minimize the attrition of weight loss program (6) Explore the trajectory of individual characteristics throughout the treatment course (7) Explore the predictor or correlate of successful weight loss, maintenance and attrition (8) Investigate the interrelationship between different behavioral, physiological, and environmental factors and their composite effect on weight loss (9) Refine the intervention and develop a further effective and individualized behavior intervention for weight loss
Detailed description
Obesity with its increasing prevalence has become a global health problem. Even modest weight loss induced by lifestyle intervention can produce clinically meaningful health benefits, however, most participants in the weight loss program fail in the longer term because of poor adherence and easy weight regain. An effective behavior therapy for weight loss is believed to have two core elements: (1) a convenient program focusing on individual response and variability, and (2) a better understanding of the predictors and correlates of weight loss outcome. Nowadays, the internet-based program featured with dynamic materials and personalized feedback has been utilized as a novel tool for weight loss. Besides, social networking site (SNS), such as Facebook, is a web-based platform for interaction. Increasing evidence demonstrated interventions through SNSs had substantial potentials on social influence and health behavior change. Research about the effectiveness of weight loss intervention via SNSs has gained much concern in recent years. Predictions of weight loss outcome based on personal characteristics are under investigation for several decades. Identifying predictors or correlates to weight loss outcome can help optimize the efficacy of the program through a better matching of intervention. Because weight loss is a is a dynamic and complex process encompassing interaction of behavioral, physiological and socio-environmental factors, a multi-factorial approach is required for research design. n this 3-year study project, investigators plan to conduct a pilot randomized control trial of a 2-year weight loss intervention that is remotely delivered via social networking site among the obese adult participants (20-64 years old, BMI ≥ 27 kg/m2) recruited from weight control clinic in medical center in Taipei, Taiwan. Investigators will survey the participants' baseline characteristics at different dimensions including personal, behavioral, physiological, social and environmental factors. Participants will be randomly assigned to a 16-week weight loss program of either enhanced intervention via Facebook or standard intervention. After the intervention, the participants will be followed for another 1 year and 8 months. The change in weight will be measured at 6 months, 12 months and 24 months after enrollment. Participants' change in attitude, behavior, and physiological condition will also be measured along the follow-up so that investigators can demonstrate the trajectory and interaction of different variables along the weight loss process. With this 3-year project, investigators not only assess the efficacy of this pilot weight loss program in Taiwan, but investigators also explore the possible predictors and correlates of successful weight loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced intervention | Experimental | Behavioral: Enhanced intervention via social networking site (SNS)Enhanced intervention features of using social-networking-site site and personalized feedback, plus standard intervention |
| Control | Active comparator | Behavioral: Standard interventionStandard intervention with regular in-person consultation |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 20-64 years
- Body mass index (BMI) ≥27 kg/m2
- Used Facebook or were willing to begin, owned a personal computer or owned a smartphone, and are healthy enough and willing to attend this program with measurement visits in 2 years.
Key exclusion criteria (5 listed)
- Pregnancy
- Previous diagnosis of diabetes mellitus
- History of psychosis, severe anxiety, major depression, panic, or Clinically diagnosed eating disorder
- History of surgical treatment for obesity
- Alcoholism or drug abuse.
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 |
|---|---|---|
| Enhanced intervention via social networking site (SNS)We plan to organize a private Facebook group serve as platform to provide the intervention content. To ensure confidentiality, this Facebook group is completely private and the group member is invited only by study staff. The participants of intervention group received information about the private Facebook group and privacy settings and were instructed to join the Facebook group. The intervention comprises three parts. Doctor patient interaction: The interventionist (physicians and dietitians) act as health coach will provide evidence-based topics related to weight loss on Facebook discussion board every two weeks | Behavioural | Enhanced intervention |
| Standard interventionIn the session, the participants are instructed by an interventionist to have a reduced calorie diet and regular physical activity. Calorie intake was prescribed based on baseline weight at 1200 kcal/d for individuals who weighed less than 90 kg, 1500 kcal/d for those who weighed 90 to less than 115 kg, and 1800 kcal/d for those who weighed 115kg or more. The interventionist will give each participants dietary recommendation and sample meal plans are provided to facilitate adoption. The interventionist will prescribe non-supervised moderate-to-vigorous physical activity to participants. Participants should start moderate-to-vigorous physical activity at 100 minutes per week and increased at 4-week intervals until a prescription of 300 minutes per week was achieved | Behavioural | Control |
Primary outcome
weight change
Time frame: 4weeks, 8weeks, 13weeks, 26weeks, 52weeks, 78weeks, 104weeks
Weight in kilogram is assessed to the nearest 0.1 kg with the participant clothed in lightweight clothing. Weight change is calculated as weight after intervention minus weight at baseline. Weight change is calculated for each participant.
3 secondary outcomes
Participants' eating behavior
Time frame: 26weeks, 52weeks, 78weeks, 104weeks
Participants' psychological distress
Time frame: 26weeks, 52weeks, 78weeks, 104weeks
Participants' quality of life
Time frame: 26weeks, 52weeks, 78weeks, 104weeks
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 2 Feb 2024.
- Individual participant dataSharing planned: No
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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 Enhanced intervention via social networking site (SNS) and Standard intervention in people with Weight Loss, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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 2 Feb 2024. 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 Taiwan. 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 change (time frame: 4weeks, 8weeks, 13weeks, 26weeks, 52weeks, 78weeks, 104weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Feb 2024.