NCT00884195

Brief Summary

This is a pilot study to evaluate the effect of keeping a 'gratitude journal' on the outcome of a weight loss program. All the subjects will be enrolled in the Lifesteps weight management program. The experimental group will maintain a gratitude journal and the control group will maintain a 'neutral' journal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 obesity

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_1 obesity

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

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 20, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

2.7 years

First QC Date

April 17, 2009

Last Update Submit

July 6, 2017

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

  • Weight loss

    3 months

Secondary Outcomes (2)

  • Quality of Life

    3 months

  • Class attendance

    3 months

Study Arms (2)

1

EXPERIMENTAL

Gratitude Journaling

Behavioral: Gratitude Journaling

2

PLACEBO COMPARATOR

Neutral Journaling

Behavioral: Neutral Journaling

Interventions

Gratitude JournalingBEHAVIORAL

Participants will be asked to write down 5 things every day for which they are grateful.

1
Neutral JournalingBEHAVIORAL

Participants will be asked to write down 5 things every day that they noticed about being involved in a weight loss program.

2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI\>25
  • \>18 years of age

You may not qualify if:

  • Severe psychiatric diagnosis which in the opinion of the PI would compromise participation in the study.
  • Addiction to alcohol and drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • CT Kappagoda, MD, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2009

First Posted

April 20, 2009

Study Start

January 1, 2009

Primary Completion

September 1, 2011

Study Completion

December 1, 2011

Last Updated

July 11, 2017

Record last verified: 2017-07

Locations

US(1)