Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Demographic variables |
Age, sex, marital status, ethnicity, education, height (to calculate BMI), and household income |
baseline (Time 0) |
|
| Primary |
Weight |
Mean difference in weight loss between groups at 6 months, in kilograms |
Change from baseline to 6 months |
|
| Secondary |
Weight |
Objective measures of weight in kilograms |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Height |
Objective measures of height in centimetres |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
BMI |
Weight and height will be combined to report BMI in kg/m^2 |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Body fat % |
Objective measures of body fat % |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Systolic and diastolic blood pressure |
Objective measures of systolic and diastolic blood pressure measured in units of millimeters of mercury (mmHg) |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Diet |
Measured with the Dietary Instrument for Nutrition Education (fatty foods, fruit and vegetable, and sugary food consumption). High scores are indicative of high consumption. Higher scores for fruit and vegetable mean a better outcome (0-3 scale; 1 item) and higher scores for fatty foods (0-24; 8 items on 0-3 scale) and sugary food (0-9; 3 items on 0-3 scale) mean a worse outcome. The minimum values are 0 and the maximum values are specified above in brackets. |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Alcohol |
Measured with the Audit C; scale 0-12, high scores are indicative of high consumption. |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Physical activity (self-reported) and sitting time |
Measured with the International Physical Activity Questionnaire short version, the minimum value is 0 (no activity), higher scores mean a better outcome. All activity will be converted to minutes before calculating MET minutes (total score). In each category a maximum of 21 hours of activity are permitted a week (3 hours X 7 days). To calculate MET minutes a week the MET value given (walking = 3.3, moderate activity = 4, vigorous activity = 8) will be multiplied by the minutes the activity was carried out and again by the number of days that that activity was undertaken. To get total MET minutes of physical activity a week the MET minutes achieved in each category (walking, moderate activity and vigorous activity) will be added. |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Sleep duration and quality |
Measured with the Pittsburgh Sleep Quality Index. In scoring the Pittsburgh Sleep Quality Index, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Health related quality of life |
Measured with the EQ-5D-5 L (this is the unabbreviated scale title), the scale has five domains each scored on 1-5 scale; min 5 maximum 25 for all domains combined) higher scores mean a worse outcome and visual analogue scale is the second part of the questionnaire, asking to mark health status on the day of the interview on a 20 cm vertical scale with end points of 0 and 100. There are notes at the both ends of the scale that the bottom rate (0) corresponds to " the worst health you can imagine", and the highest rate (100) corresponds to "the best health you can imagine". |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Number of adverse effects |
report of any adverse effects that may occur during the intervention |
Through study completion, an average of 1 year |
|
| Secondary |
Self-reported measures of intentions |
Theory-derived psychological construct measured with 2 items addressing intentions (1-5 scale), the minimum and maximum values for the scale are 2-10, and higher scores mean a better outcome (higher intentions). |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Self-reported measures of motivation |
Theory-derived psychological construct measured with 2 items addressing motivation (1-5 scale), the minimum and maximum values for the scale are 2-10, and higher scores mean a better outcome (higher motivation). |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Self-reported measures of self-efficacy |
Theory-derived psychological construct measured with 2 items addressing self-efficacy (1-5 scale), the minimum and maximum values for the scale are 2-10, and higher scores mean a better outcome (higher self-efficacy). |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Self-reported measures of attitudes |
Theory-derived psychological construct measured with 2 items addressing attitudes (1-5 scale), the minimum and maximum values for the scale are 2-10, and higher scores mean a better outcome (higher attitudes). |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Self-reported measures of action planning |
Theory-derived psychological construct measured with 8 items addressing action planning (1-5 scale), the minimum and maximum values for the scale are 8-40, and higher scores mean a better outcome (better action planning). |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Self-reported measures of coping planning |
Theory-derived psychological construct measured with 6 items addressing action planning (1-5 scale), the minimum and maximum values for the scale are 6-30, and higher scores mean a better outcome (better coping planning). |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Self-reported measures of goal facilitation |
Theory-derived psychological construct measured with 2 items addressing goal facilitation (1-5 scale), the minimum and maximum values for the scale are 2-10, and higher scores mean a better outcome (better goal facilitation) |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Self-reported measures of goal conflict |
Theory-derived psychological construct measured with 2 items addressing goal conflict (1-5 scale), the minimum and maximum values for the scale are 2-10, and higher scores mean a worse outcome (higher goal conflict) |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Self-reported measures of habit strength for physical activity |
Theory-derived psychological construct measured with h self-report behavioural automaticity index for physical activity, 4 items (1-5 scale); the minimum and maximum values for the scale are 4-20, and higher scores mean a better outcome (habit strength) |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
|
| Secondary |
Self-reported measures of habit strength for healthy eating |
Theory-derived psychological construct measured with self-report behavioural automaticity index for healthy eating, 4 items (1-5 scale); the minimum and maximum values for the scale are 4-20, and higher scores mean a better outcome (habit strength) |
baseline (Time 0), 3 months (Time 1), 6 months (Time 2) and 12 months (Time 3) |
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