NCT01032369

Brief Summary

In this randomized case control study we will evaluate the additive effect of psychological intervention, i.e CBT-cognitive behavioral treatment in a multi-strategy weight loss program composed of physical activity intervention and nutritional programme.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 15, 2009

Status Verified

December 1, 2009

Enrollment Period

1 year

First QC Date

December 13, 2009

Last Update Submit

December 14, 2009

Conditions

Keywords

Over-weight or obese subjects with learning disability who have completed "Nitzan Onim" two-year training program and live in housing within the community

Outcome Measures

Primary Outcomes (1)

  • To examine the effect of behavioral intervention-CBT on weight loss program (nutrition counselling and physical activity).

    6 months

Study Arms (2)

CBT

EXPERIMENTAL

with behavioral intervention-CBT.

Other: Nutritional intervention, physical activity and behavioral treatment

Without CBT

OTHER

Without behavioral intervention-CBT

Other: Nutritional intervention and physical activity

Interventions

Nutritional intervention: Subjects will be asked to attend weekly nutritional group's sessions and individual meetings with the dietician for nutritional treatment and follow up. Physical activity: All participants will be engaged in physical activity comprising 45-60 min training sessions 3 times a week (gym or walking).

Without CBT

Nutritional intervention: Subjects will be asked to attend weekly nutritional group's sessions and individual meetings with the dietician for nutritional treatment and follow up. Physical activity: All participants will be engaged in physical activity comprising 45-60 min training sessions 3 times a week (gym or walking). Behavioral treatment: This group will undergo behavioral treatment focusing on self control techniques using the CBT technique (cognitive behavioral therapy) which will be conducted by a clinical psychologist from "ONIM" in weekly group sessions.

CBT

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects with over-weight or obese subjects with learning disability who have completed "Nitzan Onim" two-year training program and live in housing within the community
  • Subjects who sign an informed consent

You may not qualify if:

  • Subjects with out over-weight or obese subjects with out learning disability subjects who have no completed "Nitzan Onim" two-year training program and live in housing within the community

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

OverweightObesityLearning Disabilities

Interventions

ExerciseBehavior Therapy

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 13, 2009

First Posted

December 15, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

December 15, 2009

Record last verified: 2009-12

Locations