Effectiveness of Tailored Multichannel Interventions on Weight Loss Among Adolescents: A Randomized Controlled Trial

NCT06767072 | Completed DMC

• 1 other identifier: IRB0689
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

Brief Summary

overweight among adolescents is a public health issue. However, several weight loss interventions were developed and conducted for adolescents. These interventions are often not adequately tailored to the needs of this vulnerable target group. Besides, these interventions proposed one channel is adequate to deliver the message to adolescents. The proposed study aims to evaluate the effectiveness of tailored multichannel interventions on weight loss among adolescents. The proposed study is a prospective, cluster-randomized controlled trial. 279 adolescents will be recruited from 8 non-medical colleges in Mansoura University. The 8 colleges will be randomly assigned to 4 colleges for the tailored multichannel nursing intervention or 4 colleges as a control group. For intervention participants, the tailor-based intervention will be designed and guided by a health belief model and take into evidence-based recommendations. The intervention will be designed by a multidisciplinary team and will be administered by 8 nurses for 5 months, including five face-to-face school meetings, five school-based telephone calls, and five WhatsApp text messages. Control group participants will receive 2 non-tailored face-to-face sessions. The primary outcome is the mean difference in weight loss between groups. The proposed study hypothesizes that the participants who will receive tailored multichannel intervention will lose significantly more weight (Body Mass Index) compared with the control group. Secondary outcomes include a health belief model.

Conditions

Obesity Prevention; Obesity; Overweight Adolescents; Overweight/Obesity, Adolescent; BMI; Behaviour Change; Health Promotion; Health Behavior, Risky

Keywords

digital intervention.; overweight, adolescents, tailored, health belief model, multichannel; face-to-face college meetings, telephone calls, WhatsApp text messages, and digital intervention.

Outcome Measures

Primary Outcomes (1)

• BMI

  Weight in kg and height in cm will be assessed. BMI will be measured, calculated, and interpreted based on WHO guidelines and using BMI charts. Overweight is considered when a BMI is 25 kg/m2 and Obesity is equivalent to a BMI of 30 kg/m2 or over (WHO, 2024).

  All data related to primary and secondary outcomes will be collected at baseline (T0) at 2 (T1) months, and 5 months (T2) after the start of intervention.

Secondary Outcomes (1)

• Health belief model construct

  All data related to primary and secondary outcomes will be collected at baseline (T0) at 2 (T1) months, and 5 months (T2) after the start of intervention.

Study Arms (2)

Control group

NO INTERVENTION

The CG is provided general information on overweight and obesity, and general advice to manage their weight. these will be explained to them during two college visits. CG participants will not receive tailored multichannel interventions.

Intervention Group

EXPERIMENTAL

the intervention group will receive the Tailored Multichannel interventions that will be designed by an interdisciplinary team including academic researchers from different specialties. The proposed intervention will be administered by 8 intervention nurses via multiple channels. The current intervention will be delivered using the various modes for 5 months

Behavioral: Tailored Multichannel interventions

Interventions

Tailored Multichannel interventions BEHAVIORAL

To ensure the feasibility of the intervention, the intervention will be designed by an interdisciplinary team including academic researchers from different specialties (experts in the fields of community health, psychiatry health, and nutrition), as well as 3 research assistants. The designing process for each individual in the intervention group involved the following 4 subsequent steps: (1) intervention nurses assess HBM constructs, which are used to collect data on each unique perception regarding overweight(Saghafi-Asl et al., 2020). (2) data are reviewed, identified, and summarized by the interdisciplinary team; (3) the interdisciplinary team then creates an intervention plan based on the summarized needs and (4) the intervention plan will be shared with the participant to ensure collaboration. The intervention will adopt the strategies of the Diabetes Prevention Program (DDP) (The Diabetes Prevention Program (DPP), 1996).

Intervention Group

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Students in the first and second grades of college whose body mass index (BMI) of 25 or higher at the baseline assessment will be eligible to participate in the study.

You may not qualify if:

• Students will be excluded if they have one of the following criteria.
• Students who report a physical condition or chronic illness or impairment preventing them from being physically active
• Students who have physical conditions that prevent them from losing excess body weight
• Students who are on medication that causes weight gain
• Students with a history of mental health disorders
• Students participating in another weight loss program

Sponsors & Collaborators

• Cairo University: lead
• Prince Sattam Bin Abdulaziz University: collaborator
• Mansoura University: collaborator
• British University In Egypt: collaborator
• Port Said University: collaborator

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Obesity; Overweight; Health Risk Behaviors

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Study Officials

• M A ELSHEIKH, PhD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: no masking
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Faculty of Nursing, Cairo University

Model Details: prospective, open label, barreled two groups. the study participants will be assigned randomly to intervention group or control group. the participants in the the intervention group will receive the tailored Multichannel Interventions, while the control group will receive two supportive session. the intervention group will not receive the tailored multichannel intervention.

Study Record Dates

• First Submitted: January 5, 2025
• First Posted: January 9, 2025
• Study Start: January 12, 2025
• Primary Completion: July 2, 2025
• Study Completion: July 2, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-01

Locations

EG (1)