Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns
- Conditions
- Overweight and ObesityChildhood ObesityDiabetesAdolescent ObesityAdolescent Overweight
- Interventions
- Dietary Supplement: Diet high on protein (25E%/day)Other: Increased follow-up contact after attending a weight loss camp
- Registration Number
- NCT04522921
- Lead Sponsor
- University of Aarhus
- Brief Summary
The main purpose of the present study is to perform a 10 weeks dietary intervention study with a follow-up for 52 weeks in children from 7-14 years of age with overweight or obesity. In a caloric restricted and increased physical activity setting the control group will consume a low-moderate protein (15E%/day) diet whereas the intervention group will consume a higher protein (25E%/day) diet. Furthermore, the investigators want to investigate the effect of frequent follow-up after intervention.
Compared to the low-moderate protein diet, the investigators hypothesis that a diet with higher consumption of protein-containing foods will more effectively induce weight loss (a reduction in BMI-SDS) or weight maintenance in children with overweight or obesity, and improve risk factors for type 2 diabetes and Quality of Life.
- Detailed Description
The study will be performed in collaboration with the staff of the well-established multi-component-overnight camps (Julemærkehjem) in Denmark. The multi-component-overnight camps are intensive weight loss camps to which Danish schoolchildren, from 7-14 years of age, are referred to for 10-weeks intervention focusing on healthy lifestyle, healthy eating, new habits and increased physical activity.
The primary outcome is anthropometry (BMI-SDS, fat mass, fat-free mass). Secondary outcomes are blood-tests measuring metabolic, inflammatory and liver markers and questionnaires investigating Quality of Life, Eating Behavior, Eating Habits and Disturbed Eating.
The children will be measured at baseline, 10-weeks and 52-weeks follow-up. Furthermore, participants will be invited to follow-up investigation 3 years, 5 years, 7 years and 10 years, respectively, after the intervention.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 229
- The child attends a multi-component-overnight camp in Hobro or Fjordmark between September 2020 and December 2021.
- The child is between 7 and 14 years of age (inclusive) while attending camp.
- At least one parent/guardian submit written and oral consent to participate with his/her child.
- Parent/legal guardian has submitted oral and written consent to participation of their child. In case of shared custody both parents must submit written and oral consent before their child can participate in the trial.
- The child has a disease, diagnose or eating disorder that require treatment.
- The child or parent/guardian participate in another clinical trial or plan to do so in the near future.
- The parent/guardian do not understand the written informed consent.
- The child or parent/guardian are unwilling to or unable to comply with the study protocol and instruction given by the study staff.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Intervention group (IG) Diet high on protein (25E%/day) A higher protein diet (25E%/day) for the 10 weeks they attend the camp and increased follow-up. Follow-up group (FUG) Increased follow-up contact after attending a weight loss camp Current weight-loss diet (15E%/day protein) for the 10 weeks they attend the camp and increased follow-up. Intervention group (IG) Increased follow-up contact after attending a weight loss camp A higher protein diet (25E%/day) for the 10 weeks they attend the camp and increased follow-up.
- Primary Outcome Measures
Name Time Method Change in Weight Changes from baseline to 10 weeks and 52-weeks follow-up. Weight will be measured in kilograms using a Bioelectric impedance
Change in Body Mass Index (BMI) Changes from baseline to 10 weeks and 52-weeks follow-up. Weight in kilograms and height in centimeter will be combined to report BMI in kg/m\^2
Change in Height Changes from baseline to 10 weeks and 52-weeks follow-up. Height will be measured in centimeter using a fixed wall measuring tape
Change in fat mass/fat free mass Changes from baseline to 10 weeks and 52-weeks follow-up. Fat mass/fat free mass will be measured using a Bioelectric impedance.
- Secondary Outcome Measures
Name Time Method Change in children´s well-being Changes from baseline to 10-weeks and 52-weeks follow-up Children´s well-being will be measured using the Children PedsQL4.0 questionnaire. A 5-point ordinal scale is used to score how big a problem everyday events are (the minimum value will be "never a problem" and the maximum value will be "almost always a problem"). Items are reverse-scored and linearly transformed so that higher scores indicate higher well-being.
Loss of Control Eating (LOC) episodes Will be measured three consecutive months before the intervention and three consecutive months after the intervention. LOC eating will be measured using two questions from the Eating Disorder examination questionnaire (EDE-Q 6.0) and measured on a ratio-interval scale and 0 will be the minimum value. Recurrent LOC eating is defined by \>4 LOC episodes within the past 28 days. LOC eating must be investigated over three consecutive months before evaluation.
Metabolic markers Changes from baseline to 10 weeks and 52-weeks follow-up. A blood test will collected to measure metabolic markers (HbA1c, urate, lipids (total, high-density lipoprotein (HDL)-, and low-density lipoprotein (LDL) cholesterol, and triglycerides), fasting plasma glucose). Units of measure will be the same in all.
Inflammatory markers Changes from baseline to 10 weeks and 52-weeks follow-up. A blood test will collected to measure inflammatory markers (High-sensitive C-reactive protein (hs-CRP), Interleukin(IL)-6, IL-8, leptin, adiponectin, cluster of differentiation(CD)163, CD36, fibroblast growth factor(FGF)-21, monocyte chemoattractant protein(MCP)-1, and Growth/differentiation factor (GDF)15). Units of measure will be the same in all.
Change in Eating Habits Changes from baseline to 10-weeks, 22 weeks and 52-weeks follow-up. Eating habits will be measured using the Children's Eating Habits Questionnaire-FFQ. The FFQ contains forty-three food groups clustered into thirty-six according to their nutritional profiles. On an 8-point ordinal scale children will answer how frequent they consumed different food groups (the minimum value will be "never/less than once a week" and the maximum value will be "4 or more times/week").
Change in Eating Behaviour Changes from baseline to 10-weeks, 22 weeks and 52-weeks follow-up. Eating Behaviour will be measured using the Child Eating Behaviour Questionnaire (CEBQ). CEBQ questions are grouped into 8 subgroups: food responsiveness (FR), enjoyment of food (EF), desire to drink (DD), satiety responsiveness (SR), slowness in eating (SE), food fussiness (FF), emotional overeating (EOE) and emotional undereating (EUE). Questions will be answered on a 5-point ordinal scale (the minimum value will be "never" and the maximum value will be "always"). Overweight and obese children will scores higher in 'food approach' subgroups (i.e. FR, DD, EF, EOE) and lower in 'food avoidant' subgroups (i.e. SR, SE, EUE, FF).
Liver markers Changes from baseline to 10 weeks and 52-weeks follow-up. A blood test will collected to measure liver markers (Asat, Alat, alkaline phosphatase, platlets, GGT, albumine). Units of measure will be the same in all.
Trial Locations
- Locations (2)
Weight Loss Camp Fjordmark
🇩🇰Kruså, Denmark
Weight Loss Camp Hobro
🇩🇰Hobro, Denmark