NCT02386930

Brief Summary

The primary purpose of this study is to develop a behavioral lifestyle intervention and evaluate its effectiveness in improving the glycemic control in patients with type 2 diabetes in real life setting. This is because ambiguity still exists on the effectiveness of behavioral lifestyle interventions in routine clinical practice despite of the efficacy of large randomized controlled trials, suggesting the need for more research in this area.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
Last Updated

March 12, 2015

Status Verified

March 1, 2015

Enrollment Period

11 months

First QC Date

March 7, 2015

Last Update Submit

March 7, 2015

Conditions

Type 2 Diabetes

Keywords

Cognitive behavior therapyLifestyle modificationHbA1cCarbohydrates

Outcome Measures

Primary Outcomes (1)

  • HbA1c%

    6 months

Secondary Outcomes (6)

  • Weight

    6 months

  • Body composition analysis

    6 months

  • Lipid profile ( serum cholesterol, LDL, HDL, triglycerides)

    6 months

  • Blood presssure (systolic and diastolic)

    6 months

  • carbohydrates intake in grams

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Behavrioal Lifestyle modification

EXPERIMENTAL
Behavioral: Behvarioal lifestyle modification

Control

NO INTERVENTION

Interventions

Behvarioal lifestyle modificationBEHAVIORAL

A six months behavioral lifestyle program composed of 8 sessions; 4 individual consultations and 4 telephonic calls. The cognitive behavior theory (CBT) is the underpinning theory for the lifestyle intervention; hence CBT behavioral strategies like self monitoring and goal setting are used to improve compliance to healthy lifestyle practices

Behavrioal Lifestyle modification

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Females or males. Type 2 diabetes. BMI (kg/ m²) ≥ 25. Age 18-60 years old. HbA1c \> 7%.

You may not qualify if:

  • major physical activity disability that restricts participation in moderate physical activity.
  • serious heart condition like heart failure, heart attack, stroke within the last 3 months.
  • participating in a weight management or lifestyle program. presence of proliferative retinopathy or kidney failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rashid Centre for Diabetes and Research

Ajman, United Arab Emirates

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical dietitian

Study Record Dates

First Submitted

March 7, 2015

First Posted

March 12, 2015

Study Start

July 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 12, 2015

Record last verified: 2015-03

Locations

AE(1)