Type 2 DiabetesPhase 2NCT01625507

The Alberta Diet: Effectiveness Study

A Phase 2 study testing PANDA intervention in people with Type 2 Diabetes, run by University of Alberta at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 35 to 80 years
Conditions the study is for: Type 2 Diabetes
What is being tested?: PANDA intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 1 siteCanada
Study dates: Oct 2012to Dec 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 35 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes, and speak/write English.
Have attended a diabetes education session delivered by their healthcare provider.

Who cannot join

Participants with type 1 diabetes, and those who are unable to speak English.
People with end-stage renal disease or gastrointestinal diseases that require specialized diets will also be excluded.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Alberta Diabetes Institute
Edmonton, Alberta, T6G 2R3

Other trials in Canada

About this study

Official title: The Alberta Diet: a Proposal for Its Implementation

The study hypothesis is that individuals with type 2 diabetes (T2D), who adhere to the PANDA intervention, will have improved compliance with the nutritional therapy recommendations of the Canadian Diabetes Association. Specific objectives of this proposal: The objectives of the investigators PANDA (Physical Activity and Nutrition for Diabetes in Alberta) are to (a) to devise and evaluate the efficacy of a multi-level, practical, nutrition intervention program that promotes the individual factors required for effective self-management practices AND that explicitly incorporate strategies to improve food availability, accessibility and acceptability and (b) to use these interventions as a means to examine the relationships between food availability, accessibility, acceptability, adherence to Nutrition Therapy Guidelines, and metabolic indicators of diabetes control in people with type 2 diabetes.

Conditions: Type 2 Diabetes
Being tested: PANDA intervention
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PANDA interventionBehavioural
Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes, following the recommendations of the Canadian Diabetes Association, 2008

Study groups in NCT01625507
Study group	Role	What they receive
PANDA intervention	Experimental	12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits. Receives: Behavioral: PANDA intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Total Energy Intake
Measured using repeated 24 hour dietary recalls (pre and post-intervention)
Measured: 4 months
Change in Macronutrient Intake
Measured using repeated 24 hour dietary recalls (pre and post-intervention)
Measured: 3 months
Change in Nutrient Intake
Measured using repeated 24 hour dietary recalls (pre and post-intervention)
Measured: 3 months

Secondary outcomes (10)

Change in Hemoglobin A1c
a surrogate of blood glucose control
Measured: 4 months
Program Retention
attendance at meetings
Measured: 3 months
Change in Body Mass Index
Actual weight and height used to calculate BMI pre- and post-intervention
Measured: 4 months
Body Composition
body fat and fat-free mass
Measured: 3 months
Change in Blood Biomarkers
blood lipids: triglyceride, total cholesterol, LDL-cholesterol, HDL-cholesterol
Measured: 4 months
Change in Perceived Dietary Adherence Questionnaire Score
Questionnaire assessing self-reported adherence to 9 criteria, whose individual scores (range 0-7) are summed to get the total score. Maximum total score is 63. Minimum total score is 0. A higher score means higher dietary adherence.
Measured: 4 months
Food Acceptability
questionnaire based on items related to personal and cultural acceptability of the recommended diet
Measured: 4 months
Food Accessibility
questionnaire of items related to financial and physical accessibility of foods in the diet recommended for diabetes
Measured: 4 months
Food Availability
questionnaire of items related to the availability in local stores of the food items recommended in the diet for diabetes.
Measured: 4 months
Change in Waist Circumference
Measured using repeated 24 hour dietary recalls (pre and post-intervention
Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2012Dec 2013

First posted21 Jun 2012 (estimated)
Study startOct 2012
Primary completionOct 2013
Study completionDec 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01625507
Sponsor's protocol ID: RES0013109
Status last verified: Dec 2016
First submitted: 19 Jun 2012
Last updated: 6 Feb 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 2 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Alberta Diet: a Proposal for Its Implementation
ClinicalTrials.gov ID: NCT01625507
Acronym / sponsor ID: RES0013109
Conditions: Type 2 Diabetes
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: University of AlbertaUniversity, hospital or other
Study start: Oct 2012
Primary completion: Oct 2013 (actual)
Study completion: Dec 2013 (actual)
First posted: 21 Jun 2012 (estimated)
Results: Posted 18 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
PANDA intervention	Experimental	Behavioral: PANDA intervention12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.

Who may qualify

Ages: 35 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Type 2 diabetes, and speak/write English.
Have attended a diabetes education session delivered by their healthcare provider.

Key exclusion criteria (2 listed)

Participants with type 1 diabetes, and those who are unable to speak English.
People with end-stage renal disease or gastrointestinal diseases that require specialized diets will also be excluded.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PANDA interventionParticipants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes, following the recommendations of the Canadian Diabetes Association, 2008	Behavioural	PANDA intervention

Primary outcome

Change in Total Energy Intake
Time frame: 4 months
Measured using repeated 24 hour dietary recalls (pre and post-intervention)
Change in Macronutrient Intake
Time frame: 3 months
Measured using repeated 24 hour dietary recalls (pre and post-intervention)
Change in Nutrient Intake
Time frame: 3 months
Measured using repeated 24 hour dietary recalls (pre and post-intervention)

10 secondary outcomes

Change in Hemoglobin A1c
Time frame: 4 months
Program Retention
Time frame: 3 months
Change in Body Mass Index
Time frame: 4 months
Body Composition
Time frame: 3 months
Change in Blood Biomarkers
Time frame: 4 months
Change in Perceived Dietary Adherence Questionnaire Score
Time frame: 4 months
Food Acceptability
Time frame: 4 months
Food Accessibility
Time frame: 4 months
Food Availability
Time frame: 4 months
Change in Waist Circumference
Time frame: 4 months

Results and safety

Results posted to the registry on 18 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PANDA Intervention	73	63

Primary outcome: Change in Total Energy Intake

Time frame: 4 months. Mean (95% Confidence Interval). Unit: kcal

Measure	All Participants n = 73
Value	-178 (-305 to -51)

Population analysed: All participants, intention to treat protocol

Primary outcome: Change in Macronutrient Intake

Time frame: 3 months. Mean (95% Confidence Interval). Unit: percentage of total energy

Measure	All Participants n = 73
Total fat	-1 (-3 to 0)
Saturated fat	0 (-1 to 0)
Protein	0 (0 to 1)
Carbohydrate	2 (0 to 4)
Added sugar	0 (-1 to 1)

Primary outcome: Change in Nutrient Intake

Time frame: 3 months. Mean (95% Confidence Interval). Unit: grams

Measure	All Participants n = 73
Total fat	-10 (-18 to -3)
Saturated fat	-3 (-6 to -1)
Monounsaturated fat	-3 (-6 to 0)
Polyunsaturated fat	0 (-2 to 2)
Protein	-6 (-11 to 0)
Carbohydrate	-12 (-28 to 4)
Fiber	0 (-1 to 1)
Total sugar	-5 (-13 to 2)

10 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Type 2 Diabetes

Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
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Enrolling by invitationObservational study
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Catherine B Chan, PhD principal investigator

University of Alberta

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PANDA intervention in people with Type 2 Diabetes, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Total Energy Intake (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01625507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.