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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
BEHAVIORAL - mediated physical activity promotion
BEHAVIORAL - Mental health literacy
Treatment: Drugs - placebo
BEHAVIORAL - Nutrition information
BEHAVIORAL - 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).

BEHAVIORAL: 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.

BEHAVIORAL: 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.

BEHAVIORAL: 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.

BEHAVIORAL: 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
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Depression
Timepoint [1] 0 0
Baseline, 6 weeks, 6-, 12-, 48-, and 51 month followups.
Secondary outcome [1] 0 0
Physical activity level
Timepoint [1] 0 0
Baseline, 6 weeks, 6-, 12-, 48-, and 51 month followups.
Secondary outcome [2] 0 0
Cognitive impairment
Timepoint [2] 0 0
Baseline, 12-, and 48-month followups.
Secondary outcome [3] 0 0
Physical health outcomes
Timepoint [3] 0 0
Baseline, 6-week, 6-, 12-, 24-, and 48-month followups.
Secondary outcome [4] 0 0
B12 levels
Timepoint [4] 0 0
Baseline, 12-, and 48-month followups.
Secondary outcome [5] 0 0
Folate status
Timepoint [5] 0 0
Baseline, 12-, and 48-month followups.
Secondary outcome [6] 0 0
Homocysteine
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
Sex
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
1/10/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2011
Sample size
Target
Accrual to date
Final
909
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
Government body
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
Government body
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/study/NCT00214682
Trial related presentations / publications
Walker JG, Batterham PJ, Mackinnon AJ, Jorm AF, Hickie I, Fenech M, Kljakovic M, Crisp D, Christensen H. Oral folic acid and vitamin B-12 supplementation to prevent cognitive decline in community-dwelling older adults with depressive symptoms--the Beyond Ageing Project: a randomized controlled trial. Am J Clin Nutr. 2012 Jan;95(1):194-203. doi: 10.3945/ajcn.110.007799. Epub 2011 Dec 14. Erratum In: Am J Clin Nutr. 2012 Aug;96(2):448. Dosage error in article text.
Christensen H, Aiken A, Batterham PJ, Walker J, Mackinnon AJ, Fenech M, Hickie IB. No clear potentiation of antidepressant medication effects by folic acid+vitamin B12 in a large community sample. J Affect Disord. 2011 Apr;130(1-2):37-45. doi: 10.1016/j.jad.2010.07.029.
Walker JG, Mackinnon AJ, Batterham P, Jorm AF, Hickie I, McCarthy A, Fenech M, Christensen H. Mental health literacy, folic acid and vitamin B12, and physical activity for the prevention of depression in older adults: randomised controlled trial. Br J Psychiatry. 2010 Jul;197(1):45-54. doi: 10.1192/bjp.bp.109.075291.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00214682