Obesity, Overweight
Conditions
Keywords
Intervention
Brief summary
Mothers in Motion will draw on the successes of the pilot intervention of the same name and will promote healthy lifestyle behavior changes (eating more fruits and vegetables, increasing physical activity, dealing with stress) in low-income WIC mothers of young children. The intervention group's weight change (difference between the initial enrollment and 3 months post intervention) will differ from the control group's weight change by an average of at least 2.8 pounds.
Detailed description
Mothers in Motion will draw on the successes of the pilot intervention of the same name and will promote healthy lifestyle behavior changes (eating more fruits and vegetables, increasing physical activity, dealing with stress) in low-income WIC mothers of young children. Both treatment groups will receive usual WIC care (nutrition counseling and similar services). The control group will receive generic printed health and nutrition materials to read at their own pace if they wish. The intervention group will watch the culturally sensitive DVD chapters according to a study calendar, complete action plan worksheets, and call in to peer support group teleconferences to discuss the DVD chapter contents. The teleconferences will be led by moderators trained in motivational interviewing (MI) and group facilitation. Participants will complete phone interviews and provide body weight measurements at baseline (T1), immediately after (T2) and 3 months after (T3) the intervention time period. T3 body weight will be the primary outcome.
Interventions
BEHAVIORALLifestyle Counseling
The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes
Inclusion criteria
* African American or White * Fluent in English * 18-39 years old * At least 6 weeks postpartum * Body Mass Index (BMI) between 25.0 and 39.9 * Willing to provide address and up to 3 working phone numbers * Willing to update their contact information monthly * Willing to participate in the project for 9 months * Willing to make 3 additional trips to WIC clinics for weight measures * Working DVD player at home and access to a working phone.
Exclusion criteria
* Pregnant * MIM Pilot study participation * Plan to become pregnant or relocate to a location outside of study area during the trial * Self-reported type 1 or 2 Diabetes * Unable to walk more than 1 block without resting or shortness of breath.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measured Body Weight | 3 months after the 16-week intervention (T3) | measured body weight in person at WIC office |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| T1 Fruit and Vegetable Intake | baseline | self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35. |
| T1 Physical Activity | baseline | Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity. |
| T1 Stress | baseline | Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress. |
| T2 Fat Intake | immediately after the 16-week intervention | self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68. |
| T3 Fat Intake | 3-month after the 16-week intervention | self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68. |
| T2 Fruit and Vegetable Intake | immediately after the 16-week intervention | self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35. |
| T1 Fat Intake | baseline | self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68. |
| T2 Physical Activity | immediatly after the 16-week intervention | Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity. |
| T3 Physical Activity | 3-month after the 16-week intervention | Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity. |
| T2 Stress | immediatly after the 16-week intervention | Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress. |
| T3 Stress | 3-month after the 16-week intervention | Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress. |
| Measured Body Weight | Immediatly after the 16-week intervention (T2) | measured body weight in person at WIC office |
| T3 Fruit and Vegetable Intake | 3-month after the 16-week intervention | self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lifestyle Counseling Intervention group: in addition to usual WIC care, watch the DVDs at home, complete action plan worksheets, call in to moderated (MI) group discussions.
Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention. | 387 |
| No Lifestyle Counseling Comparison group: usual WIC care; read printed materials at home
Lifestyle Counseling: The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention. | 182 |
| Total | 569 |
Baseline characteristics
| Characteristic | Lifestyle Counseling | No Lifestyle Counseling | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 387 Participants | 182 Participants | 569 Participants |
| Region of Enrollment United States | 387 participants | 182 participants | 569 participants |
| Sex: Female, Male Female | 387 Participants | 182 Participants | 569 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 387 | 0 / 182 |
| other Total, other adverse events | 0 / 387 | 0 / 182 |
| serious Total, serious adverse events | 0 / 387 | 0 / 182 |
Outcome results
Primary
Measured Body Weight
measured body weight in person at WIC office
Time frame: 3 months after the 16-week intervention (T3)
Population: The inconsistent number of participants that were reported because we conducted general linear mixed model for repeated measures, which is a partial intention-to-treat analysis (ITT), adjusting baseline assessment. We chose to perform this method without any ad hoc imputation as our approach to ITT because the overall high dropout was high
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | Measured Body Weight | 188.3 lbs | Standard Error 10.6 |
| No Lifestyle Counseling | Measured Body Weight | 187.7 lbs | Standard Error 10.6 |
p-value: >0.05Mixed Models Analysis
Secondary
Measured Body Weight
measured body weight in person at WIC office
Time frame: Immediatly after the 16-week intervention (T2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | Measured Body Weight | 188.45 lbs | Standard Deviation 10.84 |
| No Lifestyle Counseling | Measured Body Weight | 188.52 lbs | Standard Deviation 10.87 |
p-value: <0.05Mixed Models Analysis
Secondary
T1 Fat Intake
self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | T1 Fat Intake | 22.59 units on a scale | Standard Deviation 8.81 |
| No Lifestyle Counseling | T1 Fat Intake | 21.75 units on a scale | Standard Deviation 8.89 |
p-value: >0.05Mixed Models Analysis
Secondary
T1 Fruit and Vegetable Intake
self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | T1 Fruit and Vegetable Intake | 11.3 units on a scale | Standard Deviation 4.67 |
| No Lifestyle Counseling | T1 Fruit and Vegetable Intake | 10.89 units on a scale | Standard Deviation 4.64 |
p-value: <0.05Mixed Models Analysis
Secondary
T1 Physical Activity
Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | T1 Physical Activity | 14.720 hours | Standard Deviation 54.949 |
| No Lifestyle Counseling | T1 Physical Activity | 7.757 hours | Standard Deviation 19.723 |
p-value: >0.05Mixed Models Analysis
Secondary
T1 Stress
Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.
Time frame: baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | T1 Stress | 3.28 units on a scale | Standard Deviation 0.56 |
| No Lifestyle Counseling | T1 Stress | 3.24 units on a scale | Standard Deviation 0.51 |
p-value: <0.05Mixed Models Analysis
Secondary
T2 Fat Intake
self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68.
Time frame: immediately after the 16-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | T2 Fat Intake | 17.16 units on a scale | Standard Deviation 7.43 |
| No Lifestyle Counseling | T2 Fat Intake | 18.99 units on a scale | Standard Deviation 10.9 |
p-value: 0.03Mixed Models Analysis
Secondary
T2 Fruit and Vegetable Intake
self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35.
Time frame: immediately after the 16-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | T2 Fruit and Vegetable Intake | 11.11 units on a scale | Standard Deviation 4.08 |
| No Lifestyle Counseling | T2 Fruit and Vegetable Intake | 10.90 units on a scale | Standard Deviation 4.15 |
p-value: <0.05Mixed Models Analysis
Secondary
T2 Physical Activity
Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity.
Time frame: immediatly after the 16-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | T2 Physical Activity | 5.389 Hours | Standard Deviation 25.953 |
| No Lifestyle Counseling | T2 Physical Activity | 4.967 Hours | Standard Deviation 12.29 |
p-value: <0.05Mixed Models Analysis
Secondary
T2 Stress
Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.
Time frame: immediatly after the 16-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | T2 Stress | 2.56 units on a scale | Standard Deviation 0.358 |
| No Lifestyle Counseling | T2 Stress | 2.44 units on a scale | Standard Deviation 0.356 |
p-value: <0.05Mixed Models Analysis
Secondary
T3 Fat Intake
self-reported fat intake behavior using Rapid Food Screener (17 items total). Responses to each fat intake item were rated on a 5-point scale ranging from 0 (1 time or less per month) to 4 (5 or more times per week). Summed responses ranged from 0 to 68.
Time frame: 3-month after the 16-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | T3 Fat Intake | 18.42 units on a scale | Standard Deviation 8.96 |
| No Lifestyle Counseling | T3 Fat Intake | 17.22 units on a scale | Standard Deviation 10.94 |
p-value: <0.05Mixed Models Analysis
Secondary
T3 Fruit and Vegetable Intake
self-reported fruit and vegetable intake (7 items total). Responses to each fruit and vegetable intake item were rated on a 6-point scale and were rated as 0 = less than 1 time per week, 1 = once a week, 2 = 2-3 times a week, 3 = 4-6 times a week, 4 = once a day, and 5 = 2 or more times a day. Summed responses ranged from 0 to 35.
Time frame: 3-month after the 16-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | T3 Fruit and Vegetable Intake | 11.77 units on a scale | Standard Deviation 4.9 |
| No Lifestyle Counseling | T3 Fruit and Vegetable Intake | 10.97 units on a scale | Standard Deviation 6.01 |
p-value: <0.05Mixed Models Analysis
Secondary
T3 Physical Activity
Self-reported using the Pregnancy Infection and Nutrition 3 survey (24 items/activities). Participants reported frequency and duration (in hours) of physical activity that was done in seven categories and in the past 7 days. These categories were recreation (4 activities), indoor (5 activities) and outdoor (4 activities) household tasks, child and adult care (5 activities), transportation (2 activities) and activity at work and school (4 items). We first calculated hours spent on (frequency x duration) each activity, then sum all activities from 7 categories to create the total hours of moderate physical activity in the past 7 days (range 0 to 72 hours/past 7 days). The more hours, the more physical activity.
Time frame: 3-month after the 16-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | T3 Physical Activity | 4.417 Hours | Standard Deviation 16.273 |
| No Lifestyle Counseling | T3 Physical Activity | 3.666 Hours | Standard Deviation 12 |
p-value: <0.05Mixed Models Analysis
Secondary
T3 Stress
Self-report using the Perceived Stress Scale (9 items) to measure stress perception. Participants were asked about their perception of stress in the past month. Response options were scored on a 4-point scale ranging from 1 (rarely or never) to 4 (usually or always). The overall stress score was the mean of the 9-item scores, with a higher score indicating lower stress.
Time frame: 3-month after the 16-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Counseling | T3 Stress | 2.55 units on a scale | Standard Deviation 0.35 |
| No Lifestyle Counseling | T3 Stress | 2.51 units on a scale | Standard Deviation 0.356 |
p-value: <0.05Mixed Models Analysis