Self-Weighing Instruction Feasibility Study

Weight Loss Clinical Trial

Official title:

Self-Weighing Instruction Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01966926
• Other study ID #: 0807S41483
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: May 2010

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Behavioral:
• weighing frequency instructions and tips
Weekly emails with nutrition, physical activity, and weight tracking tips sent for 24 weeks

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 months
Secondary	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.	baseline to 6 months
Secondary	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.	baseline to 6 months
Secondary	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.	baseline to 6 months
Secondary	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.	baseline to 6 months
Secondary	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.	three to six months