None listed
Conditions
Brief summary
Current “best practice” weight loss guidelines promote an energy-restricted, high carbohydrate, low fat macronutrient profile. This has had limited efficacy, and highly suggests alternative strategies are needed to improve adherence to good dietary practices and sustained health outcomes, especially in children. We propose a single-arm feasibility trial to first assess the acceptability, adherence, perceived affordability and rate of attrition for this alternative diet regime, and the magnitude of change in body composition, in particular percentage body fat, and metabolic parameters (blood lipids, endocrine and inflammatory markers). Subject to successful outcomes, a RCT is planned.
Interventions
The feasibility study (n=25) was a single-arm, 12-week dietary intervention addressing short-term weight loss, health outcomes and and feasibility aspects. Children aged 8-13years consumed a diet based on whole food that aligns with a low carbohydrate, high fat (LCHF) philosophy. Once assessed for eligibility and their place confirmed on the trial, participants and their parents attended a 90 minute face-to-face workshop delivered by a Registered Dietitian and Endocrinologist (both part of the research team) detailing the dietary approach. Four of these session were conducted as recruitment took place. Participants and their families had the opportunity to answer questions during this time. They were also provided with supporting resources. which consisted of a designated website the team created specifically for this research project. Participants were not prescribed with a personalised set of energy and macronutrient requirements, but rather they were provided with general guidelines about concepts and foods to consume and to avoid on their respective diet. It was anticipated that the LCHF style of eating reflected a carbohydrate intake approximating less than the lower range of mainstream dietary recommendation i.e., <45% of total energy; a higher fat intake, approximating more than 33% of total energy, and a moderate protein intake, approximating 15-25% of total energy. Before each participant started, they attended the dietitian's clinic, where they had their weight, height and waist circumference measured. Immediately following that, they received a kit which they were to take to the hospital for their blood test, which was fasting. All anthropometric measures were conducted at the dietitian's clinic and all blood tests were conducted at Hawkes Bay Hospital. A full set of outcomes (i.e. weight, height, waist circumference and a venepuncture serum assay to assess lipids and glycaemic control were measured at weeks 0 (prior to the start of the intervention) and at week 12. At weeks 4 and 8, a weight, height and waist measure were recorded at their dietary consultation with the dietitian for monitoring and support purposes. Parents were called on the telephone each week during the 12 week intervention and asked about their child's progress. Adherence was measured during these weekly phonecalls where parents were asked what the children were eating and how well they were adhering to the protocol. Adherence was also measured each four weeks, during the consultation with the dietitian as well as in a focus group at the end of the intervention.
Sponsors
Study design
Eligibility
Inclusion criteria
8-13 year old children (free from diagnosed medical illness), with a BMI greater than the 90th percentile for age and gender according to the growth charts of the Centers for Disease Control and Prevention.
Exclusion criteria
Free from diagnosed medical illness