Overweight Clinical Trial
Official title:
Effect of Double Duty Interventions on Double Burden of Malnutrition, Dietary Diversity Score, and Frequency of Morbidity Among Secondary School Adolescents in Central Ethiopia: Cluster Randomized Controlled Trial
The goal of this cluster randomized controlled trial is to determine the effect of double duty interventions on double burden of malnutrition, dietary diversity score, and frequency of morbidity among secondary school adolescents in Debre Berhan City, Ethiopia. The main aim is to answer the following questions. 1. What is the effect of double duty interventions on double burden of malnutrition among secondary school adolescents? 2. What is the effect of double duty interventions on dietary diversity score among secondary school adolescents? 3. What is the effect of double duty interventions on among secondary school adolescents?
Introduction Double Burden of Malnutrition (DBM) is the simultaneous coexistence of undernutrition along with overweight and obesity within the same individuals, households, and populations at the national and international levels across the life course. For example, when DBM exists at the individual level, it can be occurring in the form of obesity with deficiency of one or more vitamins and minerals, or overweight in an adult who was stunted during childhood. Similarly, at the household level, it may be manifest in the forms of an overweight or anemic woman with underweight adolescents or grandparent. When it exists at the population level, the prevalence of both undernutrition and overweight/obesity can occur in the same community, nation, or region. Adolescence is a critical period in the life-course of individuals next to infancy due to highly increased growth and development. It is ranging from 10 to 19 years and is a transition period from childhood to adulthood according to WHO. It is a period in which developmental effects related to puberty and brain development lead to new sets of diets, and also a time when increased nutrient intake is required for their rapid growth. Every person obtains the social, physical, emotional, cognitive, and economic resources that are the groundwork for later life healthiness and welfare during adolescence. These resources outline paths of adolescents into the succeeding generations. Therefore, strategies, interventions, and investments in adolescent health and wellbeing bring benefits today, for decades to come, and for the next generation. Double-duty interventions (DDIs) are interventions that have the potential to simultaneously tackle the burden of both undernutrition and overnutrition or diet-related NCDs in a comprehensive manner. These interventions can be achieved in three ways. First, though not harming the existing interventions on malnutrition. Second, by retrofitting the existing nutrition interventions to address all sorts of malnutrition. Third, through the development of de novo integrated interventions (starting from the beginning, anew, or a new) aimed at the DBM. These actions reflecting the shared drivers and platforms of contrasting forms of malnutrition. Double-duty interventions also have the potential to improve nutrition outcomes across the spectrum of malnutrition through integrated initiatives, policies, and programs. It is not a zero-sum game in addressing contrasted and confounded forms of malnutrition in the global population. According to WHO 2017 policy brief, double-duty actions include about ten packages. These packages are categorized as health services packages, social safety nets packages, educational settings packages, agriculture, food systems, and food environments packages. These selected potential candidates for double-duty interventions from each setting can be summarized into four points. These interventions are optimized strong education and nutrition behavior change communication focused on promotion of healthy diets (adequate adolescent nutrition, dietary diversity), physical activity (doing proper physical exercise, avoiding sitting for log time), prevent undue harm from energy-dense foods (avoiding junk processed foods, avoiding fizzy sweetened drinks, street fast foods, chips, salt, sugar etc.), and regulations on marketing foods from the customer side (e.g., buying of packed foods frequently). For this project, the most important and selected packages will be applied. The final outcomes expected from this study are: - The proportion of secondary school adolescents with double burden of malnutrition who have received the selected double-duty interventions (DDIs). - The proportion of secondary school adolescents with high dietary diversity score (greater than or equal to 5 food groups from ten food groups) who have received the selected double-duty interventions (DDIs). - The proportion of secondary school adolescents with frequency of morbidity who have received the selected double-duty interventions (DDIs). Research Hypothesis of the Study After this study has conducted, the following proposed expected outcomes will be achieved. - The double-duty interventions will be decreased the double burden of malnutrition in adolescents. - The double-duty interventions will be increased dietary diversity score of adolescents. - The double-duty interventions will decrease the frequency of morbidity of adolescents. Methods and Materials of the Study Study area, period, and setting This study will be conducted in Debre Berhan Regiopolitan City, North Shoa Zone, Amhara Region, Central Ethiopia. Debre Berhan Regiopolitan city is located 130 km away from Addis Ababa (the capital city of Ethiopia) and 690 km from Bahir Dar (the capital city of the Amhara region). It was founded by Emperor Zara Yakoob, and it is the capital city of North Shoa Zone of Amhara region. The city has coordinated with 9°41'N 39°32'E latitude and longitude, respectively. It is found at, 2840 m above sea level, which makes it the highest city of this size in Africa. Study Design This study will be used a six-month two-arm parallel design community-based cluster randomized controlled trial using clusters (kebeles) as a unit of randomization in the city. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Terminated |
NCT03299881 -
Safety and Effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS)-Assisted Weight Loss
|
N/A | |
Completed |
NCT02805478 -
Fat-Associated Cardiovascular Organ Dysfunction
|
||
Active, not recruiting |
NCT02558920 -
Meta-analyses of Food Sources of Fructose-Containing Sugars and Obesity
|
||
Completed |
NCT03759743 -
Evaluate the Efficacy and Safety of LMT1-48 on Reducing Body Fat in Overweight Subject
|
N/A | |
Completed |
NCT03610958 -
Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.
|
N/A | |
Completed |
NCT03678766 -
CHARGE: Controlling Hunger and ReGulating Eating
|
N/A | |
Completed |
NCT04430465 -
Effects of Wholegrains on Children's Health (KORN)
|
N/A | |
Completed |
NCT04117802 -
Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome
|
N/A | |
Completed |
NCT05376865 -
Effects of Vitamin D Supplementation on Obesity, Inflammatory and Metabolic Markers
|
N/A | |
Completed |
NCT03625427 -
Effect of Palmitoleic Acid on C-reactive Protein
|
N/A | |
Active, not recruiting |
NCT03435445 -
Online Platform for Healthy Weight Loss (POEmaS)
|
N/A | |
Enrolling by invitation |
NCT05576116 -
Combined Bariatric Surgery and Pancreas After Kidney Transplantation for Type II Diabetics
|
N/A | |
Recruiting |
NCT05249465 -
Spark: Finding the Optimal Tracking Strategy for Weight Loss in a Digital Health Intervention
|
N/A | |
Active, not recruiting |
NCT06023095 -
A Study of LY3502970 in Chinese Participants With Obesity or Are Overweight With Weight-related Comorbidities
|
Phase 1 | |
Completed |
NCT03648892 -
Brain Dopamine Function in Human Obesity
|
Early Phase 1 | |
Not yet recruiting |
NCT05751993 -
Piloting a Reinforcement Learning Tool for Individually Tailoring Just-in-time Adaptive Interventions
|
N/A | |
Recruiting |
NCT02887950 -
Resistant Starch, Epigallocatechin Gallate and Chlorogenic Acid for Body Weight Loss in Menopause
|
N/A | |
Completed |
NCT02899390 -
Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes
|
N/A | |
Completed |
NCT03097237 -
High Fiber Rye Foods for Weight and Body Fat Reduction
|
N/A |