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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00214682




Registration number
NCT00214682
Ethics application status
Date submitted
14/09/2005
Date registered
22/09/2005
Date last updated
13/09/2011

Titles & IDs
Public title
Beyond Ageing Project: A Study for the Prevention of Depression
Scientific title
Beyond Ageing Project: A RCT to Assess the Benefit of Improving Mental Health Literacy as Well as the Effect of Folate and B12, and Physical Activity, in Preventing Major Depression and Cognitive Decline Among Older Australians
Secondary ID [1] 0 0
2005/483 (TGA)
Secondary ID [2] 0 0
2004/188 HREC
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Depressive Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Folate (400mcg) and Vitamin B12 (100 mcg)
Behaviour - mediated physical activity promotion
Behaviour - Mental health literacy
Treatment: Drugs - placebo
Behaviour - Nutrition information
Behaviour - pain and arthritis management information

Experimental: Folic acid (400mcg) + Vitamin B12 (100 mcg) - The vitamin intervention was a daily oral dose of one tablet consisting of folic acid 400 mcg + vitamin B12 100 mcg. The folic acid dose of 400 mcg / day was selected as it has been shown to be the dose associated with 90% of the maximal decrease in plasma homocysteine concentration for older individuals. Participants received 1 bottle x 200 tablets in six-month supplies at baseline, 6 months, 12 months, and 18 months. Adherence was monitored by telephone interviews (6 weeks, 6-, 12-, and 24 months) and 10 brief telephone tracking calls (1 - 5 weeks, and 4-, 8-, 13-, 18-, and 22-months).

Experimental: Mediated physical activity promotion - Individuals in the Physical Activity Promotion group received a manual designed to promote older individuals' physical activity participation to the level recommended to gain both physical and mental health benefits. The framework of the physical activity manual was informed by social cognitive theory and the transtheoretical model, and comprised five sections that reflect stages of behaviour change, including; precontemplation, contemplation, preparation, action, and maintenance. The manual contained evidence-based strategies and skills to assist people in increasing their physical activity levels. Participants received a pedometer at the commencement of the intervention as pedometry step / minute values are useful as an indicator of moderate to vigorous physical activity with total number of steps for one week recorded during the brief telephone calls at 1-5 weeks, and 4-, 8-, 13-, 18-, and 22- months.

Experimental: Mental health literacy - This MHL intervention comprised 10 modules, with nine of these specifically written for older adults. Modules 1 to 5 comprised information on depression and the evidence-based treatment for older adults. The additional MHL modules were booklets addressing evidence-based strategies and treatments for depression. It was delivered in a way to foster support and ensure that participants worked through the material systematically. Modules 1 to 5 were delivered in consecutive weeks as previous research indicates that the maximum impact of MHL on depressive symptoms may occur within the first six weeks of the intervention. Telephone interviewers contacted participants once a week for 5 consecutive weeks to motivate and support participants. There were an additional 5 check-in telephone calls, and Modules 6 to 10 of the MHL material that were delivered via postal mail at 4- (Module 6), 8- (Module 7), 13- (Module 8), 18- (Module 9), and 22- months (Module 10).

Placebo Comparator: Placebo tablet - A placebo tablet was the attention control intervention for the folic acid + vitamin B12 intervention group. Participants received 1 bottle x 200 tablets in 6-month supplies at baseline, 6 months, 12 months, and 18 months. Adherence was monitored by telephone interviews (6 weeks, 6-, 12-, and 24 months) and 10 brief telephone tracking calls (1 - 5 weeks, and 4-, 8-, 13-, 18-, and 22-months) during which participants counted their left-over tablets.

Active Comparator: Nutrition information - The attention control intervention for the physical activity intervention was printed nutrition literacy and included information concerning the recommended dietary guidelines for older Australians, as well as strategies and additional information to facilitate beneficial dietary behaviours. The same procedure was adhered to as the physical activity intervention to ensure adequate attention control. Participants in the nutrition promotion intervention received 5 brief telephone calls from an interviewer to facilitate adherence to the intervention, and to offer support and clarification of the materials. Participants received five further brief telephone calls as well as nutrition newsletters that were delivered via postal mail at 4-, 8-, 13-, 18-, and 22- months.

Active Comparator: Pain and arthritis management information - Pain and Arthritis Information was used as the attention control intervention for the MHL intervention and comprised 10 modules. Modules 1 to 5 were contained in an Arthritis Australia consumer guide for arthritis management. Modules 6 to 10 were a series of information pamphlets on pain management, osteoporosis and falls prevention. The delivery of the Pain Information was identical to the MHL intervention with Modules 1 to 5 distributed via postal mail in five consecutive weeks (1-5 weeks), while the remaining intervention modules were delivered at 4- (Module 6), 8- (Module 7), 13- (Module 8), 18- (Module 9), and 22- months (Module 10). Participants also received 10 brief calls from a telephone interviewer that coincided with receiving the print intervention materials.


Treatment: Drugs: Folate (400mcg) and Vitamin B12 (100 mcg)
The vitamin intervention was a daily oral dose of one tablet consisting of folic acid 400 mcg + vitamin B12 100 mcg. The folic acid dose of 400 mcg / day was selected as it has been shown to be the dose associated with 90% of the maximal decrease in plasma homocysteine concentration for older individuals. Participants received 1 bottle x 200 tablets in six-month supplies at baseline, 6 months, 12 months, and 18 months. Adherence was monitored by telephone interviews (6 weeks, 6-, 12-, and 24 months) and 10 brief telephone tracking calls (1 - 5 weeks, and 4-, 8-, 13-, 18-, and 22-months).

Behaviour: mediated physical activity promotion
Individuals in the Physical Activity Promotion group received a manual designed to promote older individuals' physical activity participation to the level recommended to gain both physical and mental health benefits. The framework of the physical activity manual was informed by social cognitive theory and the transtheoretical model, and comprised five sections that reflect stages of behaviour change, including; precontemplation, contemplation, preparation, action, and maintenance. The manual contained evidence-based strategies and skills to assist people in increasing their physical activity levels. Participants received a pedometer at the commencement of the intervention as pedometry step / minute values are useful as an indicator of moderate to vigorous physical activity with total number of steps for one week recorded during the brief telephone calls at 1-5 weeks, and 4-, 8-, 13-, 18-, and 22- months.

Behaviour: Mental health literacy
Comprises 10 modules, with nine of these specifically written for older adults. Modules 1 to 5 comprised information on depression and the evidence-based treatment for older adults. The additional MHL modules were booklets addressing evidence-based strategies and treatments for depression. It was delivered in a way to foster support and ensure that participants worked through the material systematically. Modules 1 to 5 were delivered in consecutive weeks as previous research indicates that the maximum impact of MHL on depressive symptoms may occur within the first six weeks of the intervention. Telephone interviewers contacted participants once a week for 5 consecutive weeks to motivate and support participants. There were an additional 5 check-in telephone calls, and Modules 6 to 10 of the MHL material that were delivered via postal mail at 4- (Module 6), 8- (Module 7), 13- (Module 8), 18- (Module 9), and 22- months (Module 10).

Treatment: Drugs: placebo
A placebo tablet was the attention control intervention for the folic acid + vitamin B12 intervention group. Participants received 1 bottle x 200 tablets in 6-month supplies at baseline, 6 months, 12 months, and 18 months. Adherence was monitored by telephone interviews (6 weeks, 6-, 12-, and 24 months) and 10 brief telephone tracking calls (1 - 5 weeks, and 4-, 8-, 13-, 18-, and 22-months) during which participants counted their left-over tablets.

Behaviour: Nutrition information
The attention control intervention for the physical activity intervention was printed nutrition literacy and included information concerning the recommended dietary guidelines for older Australians, as well as strategies and additional information to facilitate beneficial dietary behaviours. The same procedure was adhered to as the physical activity intervention to ensure adequate attention control. Participants in the nutrition promotion intervention received 5 brief telephone calls from an interviewer to facilitate adherence to the intervention, and to offer support and clarification of the materials. Participants received five further brief telephone calls as well as nutrition newsletters that were delivered via postal mail at 4-, 8-, 13-, 18-, and 22- months.

Behaviour: pain and arthritis management information
Pain and Arthritis Information was used as the attention control intervention for the MHL intervention and comprised 10 modules. Modules 1 to 5 were contained in an Arthritis Australia consumer guide for arthritis management. Modules 6 to 10 were a series of information pamphlets on pain management, osteoporosis and falls prevention. The delivery of the Pain Information was identical to the MHL intervention with Modules 1 to 5 distributed via postal mail in five consecutive weeks (1-5 weeks), while the remaining intervention modules were delivered at 4- (Module 6), 8- (Module 7), 13- (Module 8), 18- (Module 9), and 22- months (Module 10). Participants also received 10 brief calls from a telephone interviewer that coincided with receiving the print intervention materials.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Depression - The Patient Health Questionnaire - 9 (PHQ - 9) is a brief self-administered diagnostic instrument for depressive symptoms with items derived from the nine diagnostic criteria for Major Depression Disorder using the DSM - IV. The items are coded "0" (not at all) to "3" (nearly every day) for the most recent 2-week period, with possible scores ranging from 0 to 27, higher scores indicating greater depression severity. The PHQ - 9 is used in research and clinical settings, and can be administered via telephone. Studies support its reliability, validity, and ability to detect change over time.
Timepoint [1] 0 0
Baseline, 6 weeks, 6-, 12-, 48-, and 51 month followups.
Secondary outcome [1] 0 0
Physical activity level - The International Physical Activity Questionnaire - Short Form (IPAQ - SF) was used as a self-report measure of physical activity. The purpose of the IPAQ is to survey physical activity in large groups or populations. The IPAQ allows for a total of metabolic equivalent (MET) units expended in the most recent seven-day period.
Timepoint [1] 0 0
Baseline, 6 weeks, 6-, 12-, 48-, and 51 month followups.
Secondary outcome [2] 0 0
Cognitive impairment - The modified Telephone Interview of Cognitive Status has a max. total score= 39, and comprises 4 domains: orientation; recent memory and delayed recall; attention; and, semantic memory. It has excellent discrimination in cognitive performance in the general population. Processing speed was measured (Brief Test of Adult Cognition-Telephone) with the task to count backwards quickly from 100 by 1's for 30 seconds The Informant Questionnaire on Cognitive Decline in the Elderly was given at 2yr FU to a person who had known the participant for > 2yrs. It measures cognitive decline and dementia.
Timepoint [2] 0 0
Baseline, 12-, and 48-month followups.
Secondary outcome [3] 0 0
Physical health outcomes - A health checklist was given to determine current health status with items addressing the following health domains: cardiovascular, pulmonary, musculoskeletal, psychiatric, vision, and renal health; cancer, diabetes, and epilepsy. Blood collections were also used at baseline, 12- and 24 months to further investigate health including: thyroid stimulating hormone; liver and kidney function; fasting cholesterol and blood glucose; C-reactive protein; and haematological parameters.
Timepoint [3] 0 0
Baseline, 6-week, 6-, 12-, 24-, and 48-month followups.
Secondary outcome [4] 0 0
B12 levels - Serum vitamin B12 was measured using chemiluminscent microparticle assays (Architect i2000, Abbott Laboratories). This allowed a check on whether participants were taking the supplements, and to initially to comply with inclusion/exclusion criteria.
Timepoint [4] 0 0
Baseline, 12-, and 48-month followups.
Secondary outcome [5] 0 0
Folate status - Red cell folate was measured using chemiluminscent microparticle assays (Architect i2000, Abbott Laboratories). This allowed a check on whether participants were taking the supplements, and as part of the initial screening process to comply with our inclusion/exclusion criteria.
Timepoint [5] 0 0
Baseline, 12-, and 48-month followups.
Secondary outcome [6] 0 0
Homocysteine - A fluorescence polarization immunoassay was used for the quantitative determination of total L-homocysteine in plasma (AxSYM, Abbott Laboratories). This allowed us to establish any changes in Hcy concentration.
Timepoint [6] 0 0
Baseline, 12- and 24-month followups.

Eligibility
Key inclusion criteria
- Aged 65-74 years with some depressive symptoms, assessed using the Kessler 10
Psychological Distress Scale [K10] (Andrews & Slade, 2001)
Minimum age
65 Years
Maximum age
74 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any of the following:

- Those currently taking medication or receiving psychological treatment for depression

- A report of a medical diagnosis of bipolar disorder/mania

- History of epilepsy

- Diagnosed with cancer and/or on antifolate therapy

- Have a diagnosis of dementia or Alzheimer's disease

- Are currently taking vitamin supplements containing folate, B2, B6 or B12 at a dose
exceeding 25% of the recommended daily intake.

- Medical contradictions to exercise (e.g., significant orthopaedic problems or
cardiovascular disease that would prevent regular aerobic exercise)

- Ongoing participation in regular aerobic exercise.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 0 0
Australian National University - Canberra
Recruitment postcode(s) [1] 0 0
0200 - Canberra

Funding & Sponsors
Primary sponsor type
Other
Name
Australian National University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian Government Department of Health and Ageing
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Sydney
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Commonwealth Scientific and Industrial Research Organisation, Australia
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether folate and vitamin B12, physical activity
and mental health literacy can prevent depression, and folate and vitamin B12 and physical
activity can prevent cognitive impairment in older people. Also the study aims to assess the
benefits for older people in improving their knowledge about mental health in relation to
depression.
Trial website
https://clinicaltrials.gov/show/NCT00214682
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Professor Helen Christensen, PhD
Address 0 0
Centre for Mental Health Research, ANU
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications