Background
Rationale
Aim
Study objectives
Primary research objective
Secondary research objectives
Methods/design
Preliminary work
Study design
Study setting
Selection of subjects
Inclusion criteria
Exclusion criteria
Interventions
Active intervention
# Session | Session title | Session content | Approximate time |
---|---|---|---|
Session 1 | Preparing to Shape-up | Welcome and introduction to the programme | 25 min |
Setting ground rules for the group | 10 min | ||
Discussion about previous experience of diet and physical activity changes, how cancer has shaped their eating and activity patterns, and hopes and fears about the programme | 15 min | ||
Motivation for change | 10 min | ||
Break | 5 min | ||
Setting a lifestyle target | 10 min | ||
Information and discussion about the importance of self-monitoring and food diaries | 10 min | ||
Round-up and preparation for next session | 5 min | ||
Take-home message | 5 min | ||
Session 2 | Keeping to a regular eating pattern | Review: Discussion about self-monitoring and food diaries and goal progress | |
Volunteer-led discussion: Keeping to a regular eating pattern | |||
Key learning points: The importance of keeping to a regular eating pattern, the definition of a regular eating pattern, the importance of breakfast, suggestions for goals, and disadvantages of eating regularly. | |||
New topic: Goals and rewards | |||
Discussion about the principles of goal-setting, group exercise about setting SMART goals, exercise about goal planning, discussion about rewards, and group exercise about non-food rewards | |||
Round-up and preparation for next session | |||
Take-home message | |||
Session 3 | Physical activity | Review: Discussion about keeping a diary, setting a regular eating goal, goal-setting, rewards, and goal progress | 20 min |
Volunteer-led discussion: Physical activity | 30 min | ||
Key learning points: The importance of physical activity for health and wellbeing, the difference between physical activity and exercise, goals to aim for (30 min of moderate physical activity per day and muscle fitness exercises twice a week), and the importance of incremental increase in physical activity levels. | |||
Break | 10 min | ||
Setting an activity goal: individual exercise to help them focus on what they need to think about in order to improve their activity levels and group exercise for improving goal-setting skills | 15 min | ||
Round-up, and preparation for next session | 10 min | ||
Take-home message | 5 min | ||
Session 4 | Eating a balanced diet | Review: Discussion about last week’s topics and creating a physical activity goal and goal progress | 20 min |
Volunteer-led discussion: Getting a healthier balance of foods. | 30 min | ||
Key learning points: the five food groups, choosing which foods to make (plenty of whole grains, fruits, and vegetables; moderate amounts from the ‘meat, fish and alternatives’ and ‘milk and dairy’ groups, preferably low-fat; have little amounts of ‘foods high in fat or sugar’ and prefer healthy oils; limit processed meat, and sugary and alcoholic drinks; prefer foods low in salt). | |||
Break | 5 min | ||
New topic: Lapses | 25 min | ||
Information, group exercise, and discussion on how to deal with lapses | |||
Round-up, and preparation for next session | 5 min | ||
Take-home message | 5 min | ||
Session 5 | Keeping an eye on food serving sizes | Review: Discussion about last week’s topics, goal progress, and exercise about managing lapses | 20 min |
Volunteer-led discussion: Keeping an eye on food serving sizes | 50 min | ||
Key learning points: Each participant brings a weighed portion of some foods, and group members discuss understanding food serving sizes and how many servings they should aim for (the food servings reflect a 2,000 kcal diet for women). | |||
Break | 10 min | ||
Round-up and preparation for next session | 5 min | ||
Take-home message | 5 min | ||
Session 6 | External triggers | Review: Discussion about last week’s topics and goal progress | 20 min |
Volunteer-led discussion: External triggers | 35 min | ||
Key learning points: The difference between external and internal triggers, and main strategies for dealing with external triggers | |||
Break | 5 min | ||
New topic: Internal triggers | 20 min | ||
Discussion about hunger and cravings, group exercise for the dealing with cravings and the difference between craving and hunger and discussion about fatigue | |||
Round-up and preparation for next session | 5 min | ||
Take-home message | 5 min | ||
Session 7 | Internal triggers | Review: Discussion about last week’s topics, goal progress, and feelings about the group coming to an end | 20 min |
Volunteer-led discussion: Internal triggers | 40 min | ||
Key learning points: Definition of internal triggers (hunger, cravings, fatigue, emotions, and unhelpful thoughts) and strategies to deal with those | |||
Break | 5 min | ||
New topic: Lapse chains | 10 min | ||
Information about lapse chains and group exercise of putting together a behaviour chain | |||
Round-up, and preparation for next session | 10 min | ||
Take-home message | 5 min | ||
Session 8 | Food labels and the Shape-up change plan | Review: Discussion about last week’s topics and goal progress and reviewing earlier areas of the programme | 10 min |
Volunteer-led discussion: Food labels | 30 min | ||
Key learning points: The ingredient list and the various names of sugar and saturated fat in food labels, the importance of checking the sugar, saturated fat, and salt content in the labels, and tips for smart shopping | |||
Break | 5 min | ||
New topic: The Shape-up change plan | 20 min | ||
Information about how to complete a Shape-up change plan and individual exercise on filling a mock plan | |||
Discussion: Group members discuss their change plan, they re-evaluate their lifestyle target from Session 1, and are given information about the importance of continuing with self-monitoring | 20 min | ||
Round-up, and maintaining changes for the long term | 5 min | ||
Take-home message | 5 min |
Control group
Outcome measures
Primary outcome measures
Secondary outcome measures
Participant timeline
Study Period | |||||||
---|---|---|---|---|---|---|---|
Staff member | Pre-study screening/consent | Baseline | Allocation | Post-allocation | |||
Time point | Week -3 | Week 0 | Week 1 | Week 8 | Week 24 | ||
ENROLMENT | |||||||
Eligibility screen | Interviewer | X | |||||
Informed consent | Interviewer | X | |||||
Allocation | Study Coordinator | X | |||||
INTERVENTIONS | |||||||
Shape-up | Interviewer | ||||||
Usual care | Interviewer | ||||||
ASSESSMENTS | |||||||
Socio-demographic data | Interviewer | X | |||||
EORTC-QLQ-C30 | Interviewer | X | X | X | |||
EORTC-QLQ-EN34 | Interviewer | X | X | X | |||
Dietary assessment | Interviewer | X | X | X | |||
Physical activity | Interviewer | X | X | X | |||
Weight | Interviewer | X | X | X | |||
Height | Interviewer | X | |||||
Body composition | Interviewer | X | X | X | |||
Waist circumference | Interviewer | X | X | X | |||
Hand-grip strength | Interviewer | X | X | X | |||
Blood pressure | Interviewer | X | X | X | |||
Shape Up evaluation | Interviewer |
X
2
|
X
2
| ||||
Control group input | Interviewer | X3
| |||||
Qualitative interviews | Interviewer | X | X | ||||
Health care resource use | Interviewer | X | |||||
EQ5D-3 L | Interviewer | X | X | X | |||
Serious adverse report form | Study Coordinator | As needed throughout the protocol |