Clinical trial NCT06767072: Effectiveness of Tailored Multichannel Interventions on Weight Loss Among Adolescents: a Randomized Controlled Trial
Official title: Effectiveness of Tailored Multichannel Interventions on Weight Loss Among Adolescents: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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.
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Prince Sattam Bin Abdulaziz University
name: Mansoura University
name: British University In Egypt
name: Port Said University
First posted: 2025-01-09
Enrollment: 279
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Overweight and obesity and their related consequences are largely preventable and manageable. However, overweight is one of the most common health problems in the world. World Health Organization (WHO) reported that 12.5 % of people worldwide are overweight according to a survey of the global burden of diseases conducted in 2022. Furthermore, worldwide adult obesity has more than doubled since 1990, and adolescent obesity has quadrupled. WHO, 2024 reported that 390 million children and adolescents aged 5-19 years were overweight including 160 million who were living with obesity. Overweight and obesity are significantly correlated with an increased risk of several health disorders, such as cardiovascular disease, psychological disturbance, metabolic syndrome, type 2 diabetes, fatty liver disease, and premature death. Obesity also imposes enormous financial burdens on governments and individuals. Adolescence obesity is of particular concern as it has increased globally, and it could have adverse health impacts in adulthood.

Overall, the global prevalence of adolescent obesity is a growing public health concern, with significant physical and psychological consequences. Adolescence is a critical period where dietary habits and lifestyle behaviors are shaped, making it an ideal time for interventions aimed at promoting healthy weight management. Several preventive and treatment interventions have been conducted to enhance weight control among adolescents in different countries. However, the effectiveness of past interventions has shown inconsistent outcomes. Compliance with weight-loss treatments varies for a range of reasons, mainly related to the design and delivery of the interventions.

Systematic reviews reveal debate regarding how best to motivate adolescents to manage their ideal body weight. Empirical evidence shows that tailored interventions are often considered more effective than standardized interventions for reducing overweight among adolescents. Tailored interventions account for individual differences in lifestyle, preferences, perceptions about health and obesity, and self-efficacy. Previous studies have shown that these factors play important roles in the success of weight loss and maintenance programs. While standardized interventions can provide a solid foundation, tailoring strategies to individual needs often leads to more sustainable behavior changes and better health outcomes. Tailored interventions consider each adolescent's unique motivations, preferences, and challenges. This personalization can lead to greater engagement and adherence.

The literature suggests that interventions delivered through multiple channels-such as social media, face-to-face interactions, and telephone calls-are often more effective in addressing overweight and obesity among adolescents. Adolescents are highly engaged with digital platforms like social media, making it a natural channel of communication and providing daily reminders or motivation. Incorporating face-to-face interactions builds a personal connection and offers in-depth discussions, while telephone calls provide a direct and accessible line of communication.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: BMI
timeFrame: 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:
measure: Health belief model construct
timeFrame: 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.
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlia
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlia
Study officials:
affiliation: Cairo University
name: M A ELSHEIKH, PhD
role: PRINCIPAL_INVESTIGATOR
References: