Weight management in those with overweight and obesity Nutritional, Metabolic, Endocrine
Conditions
Interventions
Participants will be randomly allocated to one of three groups
randomisation will be stratified by age and sex and will be performed using an on-line randomisation programme. The three groups are:
1. Control group who will receive standard dietetic advice based u
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >18 years 2. Body mass index 25 - 40 kg/m² 3. Waist circumference >94 cm (for men) or >80 cm (for women) 4. Possess a mobile phone or other device capable of hosting the app 5. Able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with diabetes or having a serum glucose =125 mg/dL (6.9 mmol/l) (at V1 blood sampling), other metabolic and endocrine disorders 2. Presence of chronic disease (cardiovascular disease, kidney disease (or a serum creatinine = 1.7 mg/dl (150 µmol/l) for men and = 1.5 mg/dl (132 µmol/l) for women at V1 blood sampling), cancer, pulmonary diseases, coeliac disease, Crohn’s disease, etc.) 3. Body mass index >40 kg/m² 4. Being pregnant or planning to become pregnant within the study period 5. Use of prescribed medicine to control blood glucose, inflammation or dyslipidemia (or LDL-cholesterol =4.9 mmol/L (>190 mg/dL) and/or triglycerides =4.5 mmol/L (=400 mg/dL) at V1 blood sampling) 6. Consumption of more than 14 drinks of alcoholic beverages per week 7. Current smoking 8. Use of dietary supplements 9. Blood donation in the previous 3 months 10. No access to the internet 11. Note: Subjects with hypertension and taking antihypertensive drugs (metabolically neutral) will be not excluded and allowed to continue their prescribed dosage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Waist circumference (cm) measured using a tape measure at study entry (visit 1) and exit (visit 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hip circumference (cm) measured using a tape measure at study entry (visit 1) and exit (visit 3) 2. Waist to hip ratio (unitless) calculated from waist and hip circumferences measured at study entry (visit 1) and exit (visit 3) 3. Weight (kg) measured using weighing scales at study entry (visit 1) and exit (visit 3) 4. Body mass index (kg/m²) calculated from weight and height measurements at study entry (visit 1) and exit (visit 3) 5. Body fat mass (kg and %) and body lean mass (kg and %) by bioelectric impedance at study entry (visit 1) and exit (visit 3) 6. Dietary (amounts of foods) and nutrient (energy in calories and macronutrients in g and as % energy) intake assessed by food frequency questionnaire at study entry (visit 1) and exit (visit 3) 7. Quality of life assessed by questionnaire including a visual analog score at study entry (visit 2) and exit (visit 3) 8. Physical activity assessed by questionnaire at study entry (visit 2) and exit (visit 3) 9. Attitude to food assessed by questionnaire at study entry (visit 2) and exit (visit 3) 10. Serum glucose (mmol/l) and insulin (mU/l) concentrations at study entry (visit 1) and exit (visit 3) 11. HOMA-IR calculated using serum glucose and insulin concentrations at study entry (visit 1) and exit (visit 3) 12. Serum lipid (total, LDL and HDL cholesterol, triglycerides; all mmol/l) concentrations at study entry (visit 1) and exit (visit 3) 13. Serum adipokine (leptin, adiponectin; both ng/ml) concentrations and leptin/adiponectin ratio (unitless) at study entry (visit 1) and exit (visit 3) 14. Serum C-reactive protein (mg/l) concentration at study entry (visit 1) and exit (visit 3) 15. Plasma inflammatory biomarker (IL-6, MCP-1, IL-10, sICAM-1, sCD14, oxidized LDL; all ng/ml) concentrations at study entry (visit 1) and exit (visit 3) 16. Serum liver health markers (ALT, GGT; both U/l) at study entry (visit 1) and exit (visit 3) 17. Serum renal health markers (uric acid (mg/dl), creatinine (umol/l) at stu | — |
Countries
England, United Kingdom
Contacts
Public ContactPhilip Calder
Outcome results
None listed