Trial Outcomes & Findings for Self-Weighing Instruction Feasibility Study (NCT NCT01966926)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

6 months

Results posted on

2019-11-01

Participant Flow

Participants recruited in Sept-Oct 2009 from craigslist.com ads and flyers in a University of Minnesota office building. 58 contacted the study and 28 were excluded \[did not complete screening (n=10), not eligible due to weight or health exclusions (n=15), or withdrew before consent (n=3)\], resulting in a final sample of 30 participants.

Participant milestones

Participant milestones
Measure	Daily Weight Tracking daily weighing frequency instructions and tips	Weekly Weight Tracking weekly weighing frequency instructions and tips
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Self-Weighing Instruction Feasibility Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Daily Weight Tracking n=15 Participants daily weighing frequency instructions and tips	Weekly Weight Tracking n=15 Participants weekly weighing frequency instructions and tips	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.0 years STANDARD_DEVIATION 9.5 • n=5 Participants	46.4 years STANDARD_DEVIATION 13.8 • n=7 Participants	45.7 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	15 participants n=7 Participants	30 participants n=5 Participants
Body Mass Index	30.99 kg/m^2 STANDARD_DEVIATION 2.97 • n=5 Participants	31.08 kg/m^2 STANDARD_DEVIATION 3.37 • n=7 Participants	31.04 kg/m^2 STANDARD_DEVIATION 3.12 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All participants were included in the analysis.

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).

Outcome measures

Outcome measures
Measure	Daily Weight Tracking n=15 Participants daily weighing frequency instructions and tips	Weekly Weight Tracking n=15 Participants weekly weighing frequency instructions and tips
Adherence to Weight Tracking Instructions	98.3 percentage of postcards returned	96.7 percentage of postcards returned

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Daily Weight Tracking n=15 Participants daily weighing frequency instructions and tips	Weekly Weight Tracking n=15 Participants weekly weighing frequency instructions and tips
Changes in Depression Ratings baseline depression	3.6 units on a scale Standard Deviation 3.5	6.3 units on a scale Standard Deviation 4.4
Changes in Depression Ratings 3-month depression	3.9 units on a scale Standard Deviation 4.4	7.1 units on a scale Standard Deviation 4.1
Changes in Depression Ratings 6-month depression	4.8 units on a scale Standard Deviation 5.6	6.7 units on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Daily Weight Tracking n=15 Participants daily weighing frequency instructions and tips	Weekly Weight Tracking n=15 Participants weekly weighing frequency instructions and tips
Changes in Anxiety baseline anxiety	2.3 units on a scale Standard Deviation 2.9	5.7 units on a scale Standard Deviation 5.0
Changes in Anxiety 3-month anxiety	2.7 units on a scale Standard Deviation 3.5	5.8 units on a scale Standard Deviation 4.5
Changes in Anxiety 6-month anxiety	3.9 units on a scale Standard Deviation 6.0	5.3 units on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Daily Weight Tracking n=15 Participants daily weighing frequency instructions and tips	Weekly Weight Tracking n=15 Participants weekly weighing frequency instructions and tips
Changes in Body Image baseline body image	20.1 units on a scale Standard Deviation 7.0	19.1 units on a scale Standard Deviation 8.0
Changes in Body Image 3-month body image	22.6 units on a scale Standard Deviation 4.9	17.9 units on a scale Standard Deviation 8.6
Changes in Body Image 6-month body image	21.4 units on a scale Standard Deviation 5.9	18.5 units on a scale Standard Deviation 8.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Daily Weight Tracking n=14 Participants daily weighing frequency instructions and tips	Weekly Weight Tracking n=15 Participants weekly weighing frequency instructions and tips
Changes in Barriers to Weight Tracking 6-month barriers	30.7 units on a scale Standard Deviation 12.9	34.3 units on a scale Standard Deviation 12.4
Changes in Barriers to Weight Tracking baseline barriers	39.7 units on a scale Standard Deviation 13.1	46.7 units on a scale Standard Deviation 14.7
Changes in Barriers to Weight Tracking 3-month barriers	27.5 units on a scale Standard Deviation 9.0	37.3 units on a scale Standard Deviation 9.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Daily Weight Tracking n=15 Participants daily weighing frequency instructions and tips	Weekly Weight Tracking n=15 Participants weekly weighing frequency instructions and tips
Changes in Perceptions of Weight Tracking 3-month perceptions	47.7 units on a scale Standard Deviation 10.6	40.4 units on a scale Standard Deviation 10.2
Changes in Perceptions of Weight Tracking 6-month perceptions	48.2 units on a scale Standard Deviation 10.0	45.0 units on a scale Standard Deviation 7.7

Adverse Events

Daily Weight Tracking

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Weekly Weight Tracking

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jennifer Linde

University of Minnesota

Phone: 612-624-0065

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place