Methods Study to Characterize Early Indicators of Weight Loss in People

NCT ID: NCT00383253

Last Updated: 2009-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-03-31

Brief Summary

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Methods study to characterize early indicators of weight loss in people.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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10%

Group Type EXPERIMENTAL

caloric restriction - 10%

Intervention Type BEHAVIORAL

Subjects maintained on 10% caloric restriction (caloric intake = 90% of baseline)

25%

Group Type EXPERIMENTAL

caloric restriction - 25%

Intervention Type BEHAVIORAL

Subjects maintained on 25% caloric restriction (caloric intake = 75% of baseline)

50%

Group Type EXPERIMENTAL

caloric restriction - 50%

Intervention Type BEHAVIORAL

Subjects maintained on 50% caloric restriction (caloric intake = 50% of baseline)

Control

Group Type PLACEBO_COMPARATOR

caloric restriction - Control

Intervention Type BEHAVIORAL

Subjects maintained on their baseline caloric intake (caloric restriction = none)

Interventions

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caloric restriction - 10%

Subjects maintained on 10% caloric restriction (caloric intake = 90% of baseline)

Intervention Type BEHAVIORAL

caloric restriction - 25%

Subjects maintained on 25% caloric restriction (caloric intake = 75% of baseline)

Intervention Type BEHAVIORAL

caloric restriction - 50%

Subjects maintained on 50% caloric restriction (caloric intake = 50% of baseline)

Intervention Type BEHAVIORAL

caloric restriction - Control

Subjects maintained on their baseline caloric intake (caloric restriction = none)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Subjects \>=18 years of age with BMI \>= 30 and \< 40 kg/m2

Exclusion Criteria

* Females, those with illnesses expected to cause weight loss, those without stable body weight within 3 months of screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Adelaide

OTHER

Sponsor Role collaborator

Royal Adelaide Hospital

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Adelaide, South Australia, Australia

Site Status

Pfizer Investigational Site

North Adelaide, South Australia, Australia

Site Status

Countries

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Australia

Related Links

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Other Identifiers

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A9001342

Identifier Type: -

Identifier Source: org_study_id

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