- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01966926
Self-Weighing Instruction Feasibility Study
October 30, 2019 updated by: University of Minnesota
Scant data have been reported on the effects of weight self-monitoring during weight control.
The purpose of this pilot project was to consider the questions: Is it possible to assign participants to engage in daily weight self-monitoring, and are there differential effects on mood of daily versus weekly weighing?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study tested the feasibility of assigning participants to daily or weekly weighing, monitored adherence to weighing instructions, and tracked additional behavioral and psychosocial indicators over a period of six months.
It was hypothesized that there would be no differences in mood or adherence between daily versus weekly weighing conditions.
Knowledge about the benefits of frequent self-weighing may shape public health recommendations for regular weighing as a weight reduction or obesity prevention strategy.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55454
- University of Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Body mass index between 25 and 35 kg/m2
Exclusion Criteria:
- Current weight loss program participation
- Chronic health conditions (diabetes, cancer, heart disease, psychiatric disorders requiring medication)
- Current or past eating disorder
- Current pregnancy or pregnant in past year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Daily Weight Tracking
weighing frequency instructions and tips
|
Weekly emails with nutrition, physical activity, and weight tracking tips sent for 24 weeks
|
|
Experimental: Weekly Weight Tracking
weighing frequency instructions and tips
|
Weekly emails with nutrition, physical activity, and weight tracking tips sent for 24 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence to Weight Tracking Instructions
Time Frame: 6 months
|
Participants were assigned to daily or weekly weight tracking, and were asked to return postcards once a week with weights recorded (7 for daily, 1 for weekly).
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Depression Ratings
Time Frame: baseline to 6 months
|
Ratings of depressed mood, assessed by the Beck Depression Inventory, were obtained at baseline, three, and six months; the comparison of depression scores between groups and over time from baseline to 3 and 6 months was considered as a secondary outcome and analyzed using repeated measures multivariate analysis of variance (MANOVA).
Scores on the inventory range from 0 to 63, with higher scores indicating greater presence of depressive symptoms.
Scores from 0-10 represent normal mood; 11-16 = mild mood disturbance; 17-20 = borderline clinical depression; 21-30 = moderate depression; 31-40 = severe depression; > 40 = extreme depression.
|
baseline to 6 months
|
|
Changes in Anxiety
Time Frame: baseline to 6 months
|
Ratings of anxiety, assessed by the Beck Anxiety Inventory, were assessed at baseline, three, and six months; a comparison of anxiety scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.
Possible scores on the scale range from 0-63.
Scores from 0-7 indicate minimal anxiety; 8-15 = mild anxiety; 16-25 = moderate anxiety; 26-63 = severe anxiety.
|
baseline to 6 months
|
|
Changes in Body Image
Time Frame: baseline to 6 months
|
Changes in self-reported body image were assessed at baseline, three, and six months using the Appearance subscale of the Multidimensional Body Image Questionnaire.
The subscale has a range of 0 to 42, with higher scores indicating better body image.
A comparison of body image scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.
|
baseline to 6 months
|
|
Changes in Barriers to Weight Tracking
Time Frame: baseline to 6 months
|
Perceived barriers to self-weighing were assessed at baseline, three, and six months using a scale created for this study.
The scale has a range of 18 to 90, with higher scores indicating greater perceptions of barriers to self-weighing.
A comparison of barriers scores between groups and over time from baseline to 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.
|
baseline to 6 months
|
|
Changes in Perceptions of Weight Tracking
Time Frame: three to six months
|
Perceptions of weight tracking (ease of remembering and understanding, usefulness, awareness, interest, reward value, satisfaction, motivational value) were assessed at three and six months using a scale created for the study.
The scale has a range of 0 to 64, with higher scores indicating greater perceptions of favorability of weight tracking.
A comparison of perceptions scores between groups and over time from 3 and 6 months was considered a secondary outcome and analyzed using repeated measures MANOVA.
|
three to six months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer A Linde, Ph.D., University of Minnesota
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
October 16, 2013
First Submitted That Met QC Criteria
October 17, 2013
First Posted (Estimate)
October 22, 2013
Study Record Updates
Last Update Posted (Actual)
November 1, 2019
Last Update Submitted That Met QC Criteria
October 30, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0807S41483
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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