A Social-networking-site(SNS) Based Weight Loss Behavior Intervention- the Effect of Social Network and Multi-level Factors on Weight Loss

January 24, 2024 updated by: National Taiwan University Hospital

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Enhanced intervention
Enhanced intervention features of using social-networking-site site and personalized feedback, plus standard intervention
Behavioral: 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
Active Comparator: Control
Standard intervention with regular in-person consultation
Behavioral: Standard intervention
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4weeks, 8weeks, 13weeks, 26weeks, 52weeks, 78weeks, 104weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participants' eating behavior
Time Frame: 26weeks, 52weeks, 78weeks, 104weeks
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).
26weeks, 52weeks, 78weeks, 104weeks
Participants' psychological distress
Time Frame: 26weeks, 52weeks, 78weeks, 104weeks
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.)
26weeks, 52weeks, 78weeks, 104weeks
Participants' quality of life
Time Frame: 26weeks, 52weeks, 78weeks, 104weeks
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.)
26weeks, 52weeks, 78weeks, 104weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201612183RINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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