A multicomponent family intervention, combined with salt reduction for children with obesity: a factorial randomized study protocol.
Study Goal
The researchers aimed to evaluate the impact of reduced sodium salt with anti-inflammatory herbs on blood pressure and weight management in children with obesity and their families.
Results Summary
The study protocol includes testing reduced sodium salt's effects on blood pressure and weight metrics, but specific results are not yet reported in the abstract. The design suggests potential benefits from salt reduction combined with dietary and lifestyle interventions.
Population
Brazilian children with obesity and their families.
Effective Dosage
Not specified
Duration
1-month intervention, 1-month washout, and 1-month intervention (total 3 months with monthly visits).
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
family intervention with a Brazilian-adapted Planetary Healthy Diet (PHD) and reduced portion sizes, along with increased physical activity and reduced sedentary behavior | decrease | excessive weight gain | children with obesity | - | can reduce | #1 |
family intervention with a Brazilian-adapted Planetary Healthy Diet (PHD) and reduced portion sizes, along with increased physical activity and reduced sedentary behavior | increase | intake of in natura products and water | children with obesity | - | promotes | #2 |
family intervention with a Brazilian-adapted Planetary Healthy Diet (PHD) and reduced portion sizes, along with increased physical activity and reduced sedentary behavior | decrease | ultra-processed foods, sugar, and sodium | children with obesity | - | reduces | #3 |
reduced sodium salt plus anti-inflammatory herbs | neutral | blood pressure | families | - | evaluate salt's impact on | #4 |
family intervention with a Brazilian-adapted Planetary Healthy Diet (PHD) and reduced portion sizes, along with increased physical activity and reduced sedentary behavior | neutral | Body Mass Index (BMI) | children | - | will be the variation in | #5 |
family intervention with a Brazilian-adapted Planetary Healthy Diet (PHD) and reduced portion sizes, along with increased physical activity and reduced sedentary behavior | neutral | BMI and the variation in the blood pressure of the pair (child/mother or father) as well as waist circumference (WC) and waist-to-height ratio (WHtR) | children and parents | - | will also be measured | #6 |
recommendations of the PHD, physical activity and a salt-reduced sodium | neutral | - | - | - | will test the effectiveness | #7 |
BACKGROUND: Clinical trials to treat childhood obesity show modest results, weight regain and high dropout rates. Children with obesity often live in families with habits that contribute to unhealthy weight gain. This study will test whether a family intervention with a Brazilian-adapted Planetary Healthy Diet (PHD) and reduced portion sizes, along with increased physical activity and reduced sedentary behavior, can reduce excessive weight gain. The protocol promotes the intake of in natura products and water and reduces ultra-processed foods, sugar, and sodium. It encourages family lifestyle changes and physical activities, with randomized allocation to experimental and control groups. The responsible family member will be evaluated during follow-up. The control group will receive a print of the Brazilian dietary guideline. METHODS: A factorial crossover design will also allocate families to receive reduced sodium salt plus anti-inflammatory herbs and a placebo salt. Both the control and intervention groups will be randomly assigned to the sequence of both salts. The approach aims to reduce body weight expectations and evaluate salt's impact on blood pressure. It includes a 1-month intervention, 1-month washout, and 1-month intervention with monthly clinic visits and teleservice by health professionals. The primary outcomes will be the variation in the Body Mass Index (BMI) of the children. BMI and the variation in the blood pressure of the pair (child/mother or father) as well as waist circumference (WC) and waist-to-height ratio (WHtR) will also be measured. DISCUSSION: The project will test the effectiveness of the use of the recommendations of the PHD, physical activity and a salt-reduced sodium. The results of the present study will allow the refinement of interventions aimed at the treatment of childhood obesity and may help develop guidelines for the treatment of obesity in Brazilian children. TRIAL REGISTRATION: The study is registered in the Brazilian Registry of Clinical Trials (RBR-10 mm62vs). Registered 10 February 2023.