Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000349246
Ethics application status
Approved
Date submitted
14/02/2018
Date registered
8/03/2018
Date last updated
21/08/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Get Healthy! A pilot program to support people with intellectual disability to stay active and eat well
Scientific title
A pilot intervention to assess the feasibility and impact of running the 'Get Healthy!' physical activity and nutrition intervention for adults with intellectual disability.
Secondary ID [1] 294038 0
Nil
Universal Trial Number (UTN)
U1111-1209-3132
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Nutritional status 306575 0
Physical activity 306576 0
Sedentary behaviour 306577 0
Condition category
Condition code
Public Health 305672 305672 0 0
Health promotion/education
Physical Medicine / Rehabilitation 305710 305710 0 0
Other physical medicine / rehabilitation
Neurological 305711 305711 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a pilot healthy lifestyle intervention for adults with intellectual disability and their carers.

The active intervention runs over 12 weeks. It consists of two main components:
1) Nutrition education and meal planning support
2) Physical activity education and guided physical activity sessions

BRIEF DESCRIPTION OF PHYSICAL ACTIVITY INTERVENTION:
Intervention intensity and advice is tailored to the needs of each participant but includes a minimum of 2 contact hours per week (2X1 hour sessions per week of physical activity) for a 12 week period.

Topics to be covered in the physical activity education sessions include:
• What it means to be healthy
• Consequences of obesity
• Physical activity and screen time guidelines
• Appropriate goal setting
• Planning for maintenance and self-management
• Barriers and how to address them

10% of each 60 minute physical activity session will be dedicated to education. Approximately 40% of each session will be dedicated to aerobic exercise, 30% to strength based exercise and 20% to balance based exercise. The types and intensity of the physical activities undertaken will be tailored to the needs and interests of each participant but may include activities such as: cycling on a stationary bike, walking, supported row, horizontal squat, stair climbing, wall push ups, light dumbbell work. Mode of delivery will be face-to-face. Activities will primarily occur in a group setting, however some one to one sessions may occur if the persons level of intellectual disability or other co-morbidities require it. These sessions will all be supervised by an exercise physiologist experienced in running interventions for people with intellectual disability. The exercise physiologists will record participation rates each session.

BRIEF DESCRIPTION OF THE NUTRITION INTERVENTION:
Consists of 1 contact hour per week (1X1 hour sessions per week ) for a 12 week period. Nutrition information will be delivered in a face-to-face group setting and will be led by a qualified dietitian who will record participation rates each week. Topics covered will include: food groups, discretionary foods and healthy snacks, healthy drinks, portion size and mindful eating, and eating out choices.

Carer participants will be exposed to the same physical activity and nutrition program as people with intellectual disability, with educational materials tailored accordingly (carer program- option A). Carers in the option A program and participants with ID will be grouped separately for session delivery. In cases where carers lack the time or capacity to participate in the full program they will be offered an alternative of attending one or more phone or face-to-face sessions with the researchers. During this session/s carers will be provided with information about healthy lifestyles. They will be offered tips for supporting the person with ID to achieve their nutrition and physical activity goals (carer program- option B). There is no set minimum number or length of sessions in the carer option B program.

Physical activity sessions will be run from the UNSW Lifestyle Clinic. Nutrition sessions will be held at 3DN UNSW. Some nutrition and physical activity sessions may also occur in the community, for example, at the local park, at supervised day-care facilities or formal care residences staffed by disability care professionals. The size of each group will depend on the number of participants recruited and their level of support needs, however, in any case there will be no more than eight people per group.
Intervention code [1] 300308 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304780 0
Assess the feasibility of running the 'Get Healthy!' program with adults with intellectual disability and their carers

Feasibility will be assesses using the following methods:
Participation rates will be recorded each session: Individual participation in each nutrition session and each physical activity session will be scored (0=did not attend/1=attended but only participated minimally/2=attended and participated moderately well to very well). At the
completion of the intervention these scores will be totaled and participants will be
categorized into either high, medium or low participation groups for the purposes of
analysis.

Drop-out rates and reasons: Drop-out rates will be recorded to help determine the
acceptability of the program to participants.

Acceptability of data collection measures and procedures: The distribution of missing
data within each measure will help to determine the acceptability of measures to
program participants. Data from exit interviews with participants will also be used to
determine the acceptability of data collection measures.
Timepoint [1] 304780 0
Participation rates will be recorded each session for the entire 12 week duration of the intervention (ie- participants will receive 3 participation scores each week, one for each of the two physical activity sessions and 1 for the nutrition session)

Drop out rates and reasons will be recorded as they occur.

Feasibility of data collection measures will be assessed each time they are administered. For participants with ID and carers in the option A program the following data collection schedule is planned:

Baseline, 6 weeks, 12 weeks: Body Mass Index: (kg/m2); Waist circumference: (cm); Blood pressure: (mmHG); Cardiovascular fitness tests: (YMCA submaximal ergometer test -12 minute duration: number of minutes/stages performed, peak HR, peak workload achieved); Physical activity levels and sedentary time: (objective- steps, HR and % of sedentary behavior and light, moderate-vigorous PA / subjective- proxy report collecting information on the types and duration of PA and sedentary behaviours engaged in)

Baseline and 12 weeks only: Physical strength tests: (30 second modified push up test, medicine ball throw/chest pass, 10RM testing, 30sec Sit to Stand test); Quality of life: (PWI-ID); Dietary intake assessments: (energy intake, food group consumption and diet quality); Nutritional and physical activity knowledge (NAKS).

Additionally an exit interview will be conducted with each participant at the end of the 12 week intervention. Carers participating in option B are also offered the chance to participate in a modified exit interview.
Secondary outcome [1] 343148 0
• Body Mass Index: BMI will be calculated using the following formula (BMI = weight/height (kg/m2). Participants will be weighed to the nearest 100 grams (g). Height in metres
(m) will be measured to the nearest 1mm using a stadiometer. All participants
will be requested to wear light clothing only and to remove their shoes prior to these
measurements being taken.
Timepoint [1] 343148 0
Baseline, 6 weeks, 12 weeks
Secondary outcome [2] 343245 0
Waist Circumference (WC): To be measured pre mid and post intervention to the nearest 0.5cm. WC to be measured while the person is standing. Measurement will occur at
the midpoint between the iliac crest and the lowest rib, in full expiration.
Timepoint [2] 343245 0
Baseline, 6 weeks, 12 weeks
Secondary outcome [3] 343246 0
Cardiovascular fitness (CV Fitness): will be measured using the YMCA sub-maximal ergometer test (12 minute duration): number of minutes/stages performed, peak HR, peak workload achieved.
Timepoint [3] 343246 0
Baseline, 12 weeks
Secondary outcome [4] 343247 0
Physical activity (amount and intensity) and sedentary behaviors:

Objective PA and sedentary behavior data will be collected using a waist based GTX3 actigraph accelerometer. Participants will be asked to wear the actigraph for 5 days prior to program commencement and then for 5 days in week 12. Participants will be encouraged to wear the actigraph at all times during these days, apart from when they shower or swim. Information about steps, HR and % of sedentary behavior and light, moderate-vigorous PA will be collected.

Subjective PA and sedentary behavior data will be collected using the IPAQ-pr proxy report. Information will be collected from a carer with input from the participant themselves where possible.
Timepoint [4] 343247 0
baseline, 12 weeks
Secondary outcome [5] 343248 0
Change in physical strength: will be assessed using the 30 second modified push up test, medicine ball throw/chest pass, 10RM testing- squatting, 30sec Sit to Stand test.
Timepoint [5] 343248 0
Baseline, 12 weeks
Secondary outcome [6] 343249 0
Blood pressure: To be measured using a sphygmomanometer while the participant is seated. Participant to sit and rest for at least 5 minutes prior to blood pressure being taken. Blood pressure to be taken in both right and left arms. Forearm to be placed at heart level (mid-sternal level) during the procedure.
Timepoint [6] 343249 0
Baseline, 6 weeks, 12 weeks
Secondary outcome [7] 343250 0
Energy intake: to be assessed via:

a. 3-day photographic food record and proxy assisted 24 hour recall

b. Analysed using Foodworks® nutrition analysis software

c. Calculation of Healthy Eating Index for Australian Adults (HEIFA) to measure diet quality
Timepoint [7] 343250 0
Baseline, 12 weeks
Secondary outcome [8] 343251 0
NUTRITION AND PHYSICAL ACTIVITY KNOWLEDGE: Will be assessed using the Nutrition and Activity Knowledge Scale for Use with People with an Intellectual Disability (NAKS) questionnaire
Timepoint [8] 343251 0
Baseline, 12 weeks
Secondary outcome [9] 343252 0
QUALITY OF LIFE: To be measured using the Personal Wellbeing Index- Intellectual Disability (PWI-ID) (Cummins & Lau, 2005). This index is administered to the person as an
interview and covers the following domains:
- Standard of living
- Health
- Life achievement
- Personal relationships
- Community-connectedness
- Future security
Timepoint [9] 343252 0
baseline, 12 weeks
Secondary outcome [10] 343816 0
food group consumption to be measured using:
a. 3-day photographic food record and proxy assisted 24 hour recall

b. Analysed using Foodworks® nutrition analysis software

c. Calculation of Healthy Eating Index for Australian Adults (HEIFA) to measure diet quality
Timepoint [10] 343816 0
baseline, 12 weeks
Secondary outcome [11] 343817 0
Diet Quality: to be measured using
a. 3-day photographic food record and proxy assisted 24 hour recall

b. Analysed using Foodworks® nutrition analysis software

c. Calculation of Healthy Eating Index for Australian Adults (HEIFA) to measure diet quality
Timepoint [11] 343817 0
baseline; 12 weeks

Eligibility
Key inclusion criteria
PERSON WITH INTELLECTUAL DISABILITY GROUP:
- Intellectual disability (mild-moderate)
- Participants aged 40 years and over will be preferentially recruited but if we do not receive enough interest younger adult participants may also be included.
-Range of motion: Able to walk (with or without walking aid) for at least 10 minutes at a time based on self/carer report

CARER GROUP-OPTION A
Level of contact with participant with ID- May be either family or paid carer. Must have regular and sustained contact with a participant with ID who is enrolled in the intervention over the duration of the intervention. Regular and sustained contact is defined as at least one hour of phone or face to face contact with the participant with ID on a weekly basis.
Age- 18 years or over
Gender: all
Weight status: any
Range of motion:
- Able to walk (with or without walking aid) for at least 10 minutes at a time based on self report

CARER GROUP-OPTION B
As above apart from the fact that there are no range of motion restrictions linked to this group.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria (both ID and carer program- option A):

Extreme risk- physical health: aortic aneurysm (dissecting), aortic stenosis (severe), congestive heart failure, crescendo angina, myocardial infarction (acute), myocarditis (active or recent), current pulmonary or systemic embolism-acute, thrombophlebitis, acute infectious disease (regardless of etiology).

Extreme risk- mental health: acute psychosis, displays current challenging behavior that poses unacceptable risk of harm to self or others in the program
* Any participant who requires a medical clearance for participation, and is unable to provide one, is excluded from the study.

Mobility restrictions: Wheelchair bound, or unable to walk for at least 10 minutes for other reasons

Medication: Currently taking prescribed over the counter medication for weight loss. Currently taking beta-blocking agents

Pregnancy: Anyone who is pregnant during trial enrollment or who becomes pregnant during the course of the trial is excluded.

Non-English speaking: due to lack of translation resources participants who are unable to understand basic English are not able to participate.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is a feasibility pilot intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data Analysis Plan: Quantitative data will be analysed using the Statistical Package for Social Science (SPSS). Paired t-tests will be used to analyse normally distributed continuous variable data collected at two time points only (baseline and 12 weeks). The nonparametric Wilcoxon Signed-Ranks Test will be used in cases where data are not normally distributed. To examine any group effects of the intervention when there are two time points, we will calculate the difference from baseline in each group and then compare the mean of the differences of each group using t-tests. Regression modelling adjusting for clustering will be used to analyse data collected at three or more time points. Appropriate imputative techniques will be used to account for any missing data points. Qualitative data collected from exit interviews will be digitally recorded and transcribed verbatim. Transcribed data will be thematically analysed to identify program strengths, weaknesses, suggestions for improvement, and overall perceived impact. The software program NVivo will be used to support organization of qualitative data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/01/2018
Date of last participant enrolment
Anticipated
16/04/2018
Actual
16/04/2018
Date of last data collection
Anticipated
16/07/2018
Actual
16/07/2018
Sample size
Target
12
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298663 0
Government body
Name [1] 298663 0
NSW Department of Family and Community Services provided funding for this project under the Community Services/Liveable Communities Grants Program.
Country [1] 298663 0
Australia
Primary sponsor type
Individual
Name
Prof Julian Trollor (UNSW Sydney)
Address
The Department of Developmental Disability Neuropsychiatry
34 Botany St
UNSW Sydney
NSW
2052 Australia
Country
Australia
Secondary sponsor category [1] 297831 0
None
Name [1] 297831 0
Address [1] 297831 0
Country [1] 297831 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299617 0
UNSW Sydney HREC
Ethics committee address [1] 299617 0
Ethics committee country [1] 299617 0
Australia
Date submitted for ethics approval [1] 299617 0
Approval date [1] 299617 0
12/07/2017
Ethics approval number [1] 299617 0
HC17471

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 81046 0
Prof Julian Trollor
Address 81046 0
34 Botany St
UNSW Sydney
NSW 2052
Country 81046 0
Australia
Phone 81046 0
+61 2 99319160
Fax 81046 0
+61 2 99319154
Email 81046 0
[email protected]
Contact person for public queries
Name 81047 0
Julian Trollor
Address 81047 0
34 Botany St
UNSW Sydney
NSW 2052
Country 81047 0
Australia
Phone 81047 0
+61 2 99319160
Fax 81047 0
+61 2 99319154
Email 81047 0
[email protected]
Contact person for scientific queries
Name 81048 0
Julian Trollor
Address 81048 0
34 Botany St
UNSW Sydney
NSW 2052
Country 81048 0
Australia
Phone 81048 0
+61 2 99319160
Fax 81048 0
+61 2 99319154
Email 81048 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Embase'Get Healthy!' A physical activity and nutrition program for older adults with intellectual disability: Pilot study protocol.2018https://dx.doi.org/10.1186/s40814-018-0333-1
Embase'Get Healthy!' physical activity and healthy eating intervention for adults with intellectual disability: results from the feasibility pilot.2023https://dx.doi.org/10.1186/s40814-023-01267-5
N.B. These documents automatically identified may not have been verified by the study sponsor.