Specialty: Public Health, Primary sub-specialty: Public health
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: People were eligible to take part if they: 1. Were at least 16 years old 2. Had a BMI of 25kg/m2 or more 3. Owned an Android-based smartphone 4. Lived within a travelling distance (up to 40 minutes) from Exeter, UK
Exclusion criteria
Exclusion criteria: People who: 1. Are excluded by eligibility criteria of Health Promotion Devon (see 171) 2. Are currently pregnant 3. BMI of =45 kg/m2. When a person reaches a BMI of 45kg/m2 lifestyle modification is more complex and challenging, requiring specialist (Tier 3) services or bariatric surgery may be recommended (National Institute for Health and Clinical Excellence, 2006), making it unsuitable for them to take part in the current study 3. Do not speak or understand written English 4. Are participating in concurrent interventional research which may overburden the patient or confound data collection (e.g., another weight loss trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For this feasibility RCT, the main outcomes of interest were: 1. Uptake rate (percentage of participants eligible to take part consenting to be randomised) 2. Retention rate (the percentage of randomised individuals providing data at three months) 3. The standard deviation of weight loss at three months of follow up Other feasibility outcomes of interest were measures-completion rates (the percentage of randomised participants who completed each measure at each time point) and acceptability of the intervention and the study procedures (percent satisfied with the ImpulsePal app and study procedures). Primary outcome for main trial (weight) was measured to estimate standard deviations to inform sample size calculation. Weight was measured objectively using calibrated Seca 899 weighing scale at baseline, 1 month, and 3 months. Height was measured using the Seca 213 portable stadiometer at baseline only to calculate BMI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes for the full-scale trial were also measured as follows: 1. Unhealthy snack food/drink consumption was measured using a 7-day recall 11-item food frequency questionnaire (FFQ) adapted from a questionnaire used by Churchill and Jessop (Churchill & Jessop, 2011) at baseline, 1 month, and 3 months 2. Frequency of overeating was measured using the three items from the Eating Disorder Examination Questionnaire (EDE-Q) referring to the frequency of overeating episodes and loss of control and the number of days uncontrolled eating occurred (over a period of 28 days) Process measures for use in the full-scale trial were also used to assess their feasibility as follows: 1. Impulsiveness was measured using the short form Barratt Impulsiveness Scale (BIS-Q) 2. Food cravings were measured using the short form Food Cravings Questionnaire -Trait (FCQ-T-reduced) 3. Sensitivity to the food environment was measured using the Power of Food Scale (PFS) 4. Self-efficacy was measured using a constructed self-efficacy questionnaire which includes items referring to situations where food temptations and cravings commonly arise which make it difficult to stick to a healthy eating goal (as identified through service user involvement) 5. Fidelity checks in terms of the delivery, receipt, and enactment of the separate intervention components | — |
Countries
United Kingdom