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

NCT06237933 | Completed

• 1 other identifier: 201612183RINB
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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.

  4weeks, 8weeks, 13weeks, 26weeks, 52weeks, 78weeks, 104weeks

Secondary Outcomes (3)

• Participants' eating behavior

  26weeks, 52weeks, 78weeks, 104weeks

• Participants' psychological distress

  26weeks, 52weeks, 78weeks, 104weeks

• Participants' quality of life

  26weeks, 52weeks, 78weeks, 104weeks

Study Arms (2)

Enhanced intervention

EXPERIMENTAL

Enhanced intervention features of using social-networking-site site and personalized feedback, plus standard intervention

Behavioral: Enhanced intervention via social networking site (SNS)

Control

ACTIVE COMPARATOR

Standard intervention with regular in-person consultation

Behavioral: Standard intervention

Interventions

Enhanced intervention via social networking site (SNS) BEHAVIORAL

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

Enhanced intervention

Standard intervention BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 20 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: February 2, 2024
• Study Start: August 1, 2017
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)