Self-Weighing Instruction Feasibility Study
Primary Purpose
Weight Loss, Body Weight
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
weighing frequency instructions and tips
Sponsored by
About this trial
This is an interventional other trial for Weight Loss focused on measuring self monitoring, self weighing, weight tracking, psychosocial outcomes, feasibility
Eligibility Criteria
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
Sites / Locations
- University of Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Daily Weight Tracking
Weekly Weight Tracking
Arm Description
weighing frequency instructions and tips
weighing frequency instructions and tips
Outcomes
Primary Outcome Measures
Adherence to Weight Tracking Instructions
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).
Secondary Outcome Measures
Changes in Depression Ratings
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.
Changes in Anxiety
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.
Changes in Body Image
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.
Changes in Barriers to Weight Tracking
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.
Changes in Perceptions of Weight Tracking
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.
Full Information
NCT ID
NCT01966926
First Posted
October 16, 2013
Last Updated
October 30, 2019
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT01966926
Brief Title
Self-Weighing Instruction Feasibility Study
Official Title
Self-Weighing Instruction Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Body Weight
Keywords
self monitoring, self weighing, weight tracking, psychosocial outcomes, feasibility
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daily Weight Tracking
Arm Type
Experimental
Arm Description
weighing frequency instructions and tips
Arm Title
Weekly Weight Tracking
Arm Type
Experimental
Arm Description
weighing frequency instructions and tips
Intervention Type
Behavioral
Intervention Name(s)
weighing frequency instructions and tips
Intervention Description
Weekly emails with nutrition, physical activity, and weight tracking tips sent for 24 weeks
Primary Outcome Measure Information:
Title
Adherence to Weight Tracking Instructions
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in Depression Ratings
Description
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.
Time Frame
baseline to 6 months
Title
Changes in Anxiety
Description
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.
Time Frame
baseline to 6 months
Title
Changes in Body Image
Description
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.
Time Frame
baseline to 6 months
Title
Changes in Barriers to Weight Tracking
Description
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.
Time Frame
baseline to 6 months
Title
Changes in Perceptions of Weight Tracking
Description
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.
Time Frame
three to six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer A Linde, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
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Self-Weighing Instruction Feasibility Study
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