ObesityNCT04649047
Lifestyle Behavior Weight Loss Intervention
A study testing Goal-oriented episodic future thinking in people with Obesity and Weight Loss, run by Ohio State University at 1 site in United States.
Trial summary
This lifestyle behavior intervention aims to weight loss in low-income overweight or obese mothers of young children through promotion of stress management, healthy eating, and physical activity. All eligible women will be assigned to the intervention group. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Weight Loss
- What is being tested?
- Goal-oriented episodic future thinking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index of 25.0-39.9 kg/m2 (calculated using height and weight)
- Current enrollment in government assistant programs (for example, WIC, food stamp (SNAP), or Madicaid)
- 6 weeks - 3.5 years postpartum
- 18-45 years old
- Fluency in speaking, reading, and writing English
- Ownership of a smart phone with unlimited text messages and internet access
- Committed to a three-week intervention study
Who cannot join
- Current pregnancy or lactation
- Plan to become pregnant during the trial
- Type 1 or 2 diabetes
- Untreated thyroid disease
- Drug or alcohol abuse or dependence within last six months
- Major psychiatric disorder (e.g., schizophrenia, bipolar)
Show all 12Show fewer
- History of bulimia or anorexia
- Current taking of appetite suppressant or (antipsychotic) medications known to affect body weight
- Current participation in a weight control or drug study
- Current or planned participation in a commercial weight loss program
- Previous weight loss surgery
- Contraindications to physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weight Loss Intervention for Mothers With Young Children
This lifestyle behavior intervention aims to weight loss in low-income overweight or obese mothers of young children through promotion of stress management, healthy eating, and physical activity. All eligible women will be assigned to the intervention group. The intervention will last 3 weeks and will be delivered via weekly web and individual health coaching sessions.
Read the detailed description
Previous research in lifestyle behavior weight loss intervention has 3 limitations. (1) Low-income overweight or obese mothers of young children have been significantly underrepresented. (2) Prior lifestyle interventions in overweight or obese mothers have suffered from threats to internal validity and have not specifically addressed motivation, emotion, and cognition (especially executive function), all of which are critical for promoting and maintaining healthy lifestyle behaviors and health outcomes. (3) There has been little evidence that any of the potentially efficacious strategies researched previously were even possible under real-world conditions. The proposed small pilot study builds on strength and effectively addresses limitations of prior research. The ultimate goal of the proposed study is to create a more feasible and scalable intervention that can be easily implemented and sustained in real-world settings. This self-directed, web-based goal-oriented episodic future thinking intervention will focus on increasing motivation (autonomous motivation and self-efficacy) and improving emotion (emotion control and stress) and cognition (impulsivity). the will lead to weight loss and decrease risk of chronic conditions associated with obesity, for example, hypertension, type 2 diabetes, and cancer. All eligible women will be assigned to the intervention group. The intervention will last 3 weeks and will be delivered via weekly web and individual health coaching sessions. We will enroll 30 low-income overweight or obese mothers of young children with diverse racial and ethnic backgrounds. All participants will be assessed at baseline (T1) and immediately after the three-week intervention (T2). Specific aims are to to (1) assess intervention fidelity (dose, delivery, receipt) and acceptability by the study participants, (2) investigate potential intervention impact on the primary (body weight) and secondary outcomes (waist circumference), (3) explore potential intervention impact on lifestyle behaviors (diet and physical activity), (4) explore potential intervention impact on motivation (autonomous motivation, self-efficacy, social support), emotion (emotion control, stress), and cognition (impulsivity), and (5) assess cost of different recruitment approaches.
- Conditions
- Obesity, Weight Loss
- Being tested
- Goal-oriented episodic future thinking
- Keywords
- low-income women, weight loss
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-oriented episodic future thinkingBehavioural
All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity Receives: Behavioral: Goal-oriented episodic future thinking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Self-reported body weight
Measured: baseline (T1) and 3 weeks follow up (T2)
Secondary outcomes (13)
Body Mass Index
kg/m^2
Measured: baseline (T1) and 3 weeks follow up (T2)
Daily Dietary Fat Intake
NCI brief dietary fat intake survey was used to measure dietary fat intake. Participants reported the frequency of each specific food eaten over the past 12 months. Values are:1 = never, 2 = less than once per month,3 = 1-3 times per week, 4 = 3-4 times per week,5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 or more times per day. Higher scores indicate more frequent fat intake.There is no minimum or maximum available for this measure.
The following procedures were used to convert an individual's responses to an estimate of that individual's percentage energy from fat: The frequency reported categorically on the questionnaire was converted to the number of times fat was consumed per day as shown below. In general, the midpoint of the frequency range was used.
Never 0.0 Less than once a month 0.018 1-3 times per month 0.066 1-2 times per week 0.214 3-4 times per week 0.499 5-6 times per week 0.784
- time per day 1.0
- or more times per day 2.0
Measured: baseline (T1) and 3 weeks follow up (T2)
Daily Fruit and Vegetable Intake
NCI brief Fruit and Vegetable intake survey was used to measure dietary intake. Participants reported the frequency of each specific food eaten over the past 12 months. Values are:1 = never, 2 = less than once per month,3 = 1-3 times per week, 4 = 3-4 times per week,5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 or more times per day. Higher scores indicate more frequent fruit and vegetable intake.There is no minimum or maximum available for this measure.
The frequency reported categorically on the questionnaire was converted to the number of times fruits/vegetables were consumed per day as shown below. In general, the midpoint of the frequency range was used.
Frequency ResponseTimes Per Day Never 0.0 Less than once a month 0.018 1-3 times per month 0.066 1-2 times per week 0.214 3-4 times per week 0.499 5-6 times per week 0.784
- time per day 1.0
- or more times per day 2.0
Measured: baseline (T1) and 3 weeks follow up (T2)
Frequency of Added Sugar Intake
NCI brief Added Sugar intake survey was used to measure dietary intake. Participants reported the frequency of each specific food eaten over the past 12 months. Values are:1 = never, 2 = less than once per month,3 = 1-3 times per week, 4 = 3-4 times per week,5 = 5-6 times per week, 6 = 1 time per day, 7 = 2 or more times per day. Higher scores indicate more frequent fat intake.There is no minimum or maximum available for this measure.
The frequency reported categorically on the questionnaire was converted to the number of times consumed per day as shown below. In general, the midpoint of the frequency range was used.
Frequency ResponseTimes Per Day Never 0.0 Less than once a month 0.018 1-3 times per month 0.066 1-2 times per week 0.214 3-4 times per week 0.499 5-6 times per week 0.784
- time per day 1.0
- or more times per day 2.0
Measured: baseline (T1) and 3 weeks follow up (T2)
Daily Physical Activity (Metabolic Equivalent Task MET)
The International Physical Activity Questionnaire Short Form (7 items) was be used to measure physical activity. Participants are asked to report frequency (days/week) and duration (hours/ day or minutes/day) of vigorous and moderate physical activities performed in the past 7 days.
Participants were asked about 3 specific types of activity: walking, moderate-intensity activity, and vigorous-intensity activity. Participants also reported frequency (days per week) and duration (time per day) for each specific type of activity. To create metabolic equivalent of task (MET, energy expenditure) measures, we multiplied frequency by duration (in hours). We then used the summation times 3.3 MET (walking), 4.0 (moderate physical activity), and 8.0 (vigorous physical activity) to generate physical activity scores in MET units. Higher scores indicated more energy expenditure.
Measured: baseline (T1) and 3 weeks follow up (T2)
Change in Autonomous Motivation for Stress Management
Autonomous motivation. To measure autonomous motivation, we used the Treatment Self-Regulation Questionnaire (6 items for stress management). Participants rated how true each statement was for them related to stress management using a 7-point scale: 1 (not at all true) to 7 (very true). We summed responses to the 6 items to create a score for stress management. Scores can range from 6 - 42. Higher scores indicated higher autonomous motivation.
Measured: baseline (T1) and 3 weeks follow up (T2)
Change in Autonomous Motivation for Healthy Eating
Autonomous motivation. To measure autonomous motivation, we used the Treatment Self-Regulation Questionnaire (6 items for healthy eating). Participants rated how true each statement was for them related to healthier eating using a 7-point scale: 1 (not at all true) to 7 (very true). We summed responses to the 6 items to create a score for healthy eating. Scores can range from 6 - 42 Higher scores indicated higher autonomous motivation.
Measured: baseline (T1) and 3 weeks follow up (T2)
Change in Autonomous Motivation for Physical Activity
Autonomous motivation. To measure autonomous motivation, we used the Treatment Self-Regulation Questionnaire (6 items for physical activity). Participants rated how true each statement was for them related to physical activity using a 7-point scale: 1 (not at all true) to 7 (very true). We summed responses to the 6 items to create a score for physical activity. Scores can range from 6 -42. Higher scores indicated higher autonomous motivation.
Measured: baseline (T1) and 3 weeks follow up (T2)
Change in General Self-efficacy
Self-efficacy. We used surveys to measure self-efficacy. We also used the general self-efficacy scale (10 items) to measure self-efficacy. Participants rated the truthfulness of each statement using a 4-point scale: 1 (not at all true) to 4 (exactly true). We summed responses to the 10 items to create a score for general self-efficacy. Scores can range from 10 - 40. Higher scores meant higher self-efficacy.
Measured: baseline (T1) and 3 weeks follow up (T2)
Change in Healthy Eating Self-efficacy
Self-efficacy. We used surveys to measure self-efficacy for healthy eating (8 items). Participants rated levels of confidence using a 4-point scale: 1 (not at all confident) to 4 (very confident). We summed responses to the 8 items to create a score for self-efficacy for healthy eating. THigher scores meant higher self-efficacy. Participants rated the truthfulness of each statement using a 4-point scale: 1 (not at all true) to 4 (exactly true). We summed responses to the 10 items to create a score for general self-efficacy.
Scores can range from 8 - 32. Higher scores meant higher self-efficacy.
Measured: baseline (T1) and 3 weeks follow up (T2)
Change in Physical Activity Self-efficacy
Self-efficacy. We used surveys to measure physical activity (10 items). Participants rated levels of confidence using a 4-point scale: 1 (not at all confident) to 4 (very confident). We summed responses to the 10 items to create a score for self-efficacy for physical activity. Higher scores meant higher self-efficacy. Participants rated the truthfulness of each statement using a 4-point scale: 1 (not at all true) to 4 (exactly true). We summed responses to the 10 items to create a score for general self-efficacy. Scores can range from 10 - 40. Higher scores meant higher self-efficacy.
Measured: baseline (T1) and 3 weeks follow up (T2)
Change in Emotion Regulation
Emotional control. To measure emotional control, we used the Emotion Regulation Questionnaire to assess the emotional regulatory process using reappraisal (6 items) and suppression (4 items). Participants rated the degree of agreement using a 7-point scale: 1 (strongly disagree) to 7 (strongly agree). The suppression items were reverse coded prior to score computation. We summed responses to the 10 items to create a score for emotional control. Scores could range between 10 - 70. Higher scores meant better emotional control.
Measured: baseline (T1) and 3 weeks follow up (T2)
Change in Perceived Stress
We used the Perceived Stress Scale (10 items) to measure stress. Participants rated the frequency of stressful life situations in the past month using a 4-point scale: 1 (never) to 4 (often). We summed responses to the 10 items to create a score for stress. Scores can range from 10-40. Higher scores meant perceived higher levels of stress.
Measured: baseline (T1) and 3 weeks follow up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start1 Feb 2021
- Primary completion1 Feb 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei-Wei Chang, Ohio State University
- Investigators
- Mei-Wei Chang, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649047
- Sponsor's protocol ID
- 2020B0322
- Status last verified
- Jan 2025
- First submitted
- 24 Nov 2020
- Last updated
- 31 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Intervention for Mothers With Young Children
- ClinicalTrials.gov ID
- NCT04649047
- Acronym / sponsor ID
- 2020B0322
- Conditions
- Obesity, Weight Loss
- Keywords
- low-income women, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Posted 31 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This lifestyle behavior intervention aims to weight loss in low-income overweight or obese mothers of young children through promotion of stress management, healthy eating, and physical activity. All eligible women will be assigned to the intervention group. The intervention will last 3 weeks and will be delivered via weekly web and individual health coaching sessions.
Detailed description
Previous research in lifestyle behavior weight loss intervention has 3 limitations. (1) Low-income overweight or obese mothers of young children have been significantly underrepresented. (2) Prior lifestyle interventions in overweight or obese mothers have suffered from threats to internal validity and have not specifically addressed motivation, emotion, and cognition (especially executive function), all of which are critical for promoting and maintaining healthy lifestyle behaviors and health outcomes. (3) There has been little evidence that any of the potentially efficacious strategies researched previously were even possible under real-world conditions. The proposed small pilot study builds on strength and effectively addresses limitations of prior research. The ultimate goal of the proposed study is to create a more feasible and scalable intervention that can be easily implemented and sustained in real-world settings. This self-directed, web-based goal-oriented episodic future thinking intervention will focus on increasing motivation (autonomous motivation and self-efficacy) and improving emotion (emotion control and stress) and cognition (impulsivity). the will lead to weight loss and decrease risk of chronic conditions associated with obesity, for example, hypertension, type 2 diabetes, and cancer. All eligible women will be assigned to the intervention group. The intervention will last 3 weeks and will be delivered via weekly web and individual health coaching sessions. We will enroll 30 low-income overweight or obese mothers of young children with diverse racial and ethnic backgrounds. All participants will be assessed at baseline (T1) and immediately after the three-week intervention (T2). Specific aims are to to (1) assess intervention fidelity (dose, delivery, receipt) and acceptability by the study participants, (2) investigate potential intervention impact on the primary (body weight) and secondary outcomes (waist circumference), (3) explore potential intervention impact on lifestyle behaviors (diet and physical activity), (4) explore potential intervention impact on motivation (autonomous motivation, self-efficacy, social support), emotion (emotion control, stress), and cognition (impulsivity), and (5) assess cost of different recruitment approaches.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Goal-oriented episodic future thinkingAll participants will be assigned to the experimental group and receive a 3-weekly intervention via web and individual health coaching. The educational topics cover stress management, healthy eating, and physical activity |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Body mass index of 25.0-39.9 kg/m2 (calculated using height and weight)
- Current enrollment in government assistant programs (for example, WIC, food stamp (SNAP), or Madicaid)
- 6 weeks - 3.5 years postpartum
- 18-45 years old
- Fluency in speaking, reading, and writing English
Key exclusion criteria (12 listed)
- Current pregnancy or lactation
- Plan to become pregnant during the trial
- Type 1 or 2 diabetes
- Untreated thyroid disease
- Drug or alcohol abuse or dependence within last six months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal-oriented episodic future thinkingAll participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity | Behavioural | Intervention |
Primary outcome
Change in Body Weight
Time frame: baseline (T1) and 3 weeks follow up (T2)
Self-reported body weight
13 secondary outcomes
Body Mass Index
Time frame: baseline (T1) and 3 weeks follow up (T2)
Daily Dietary Fat Intake
Time frame: baseline (T1) and 3 weeks follow up (T2)
Daily Fruit and Vegetable Intake
Time frame: baseline (T1) and 3 weeks follow up (T2)
Frequency of Added Sugar Intake
Time frame: baseline (T1) and 3 weeks follow up (T2)
Daily Physical Activity (Metabolic Equivalent Task MET)
Time frame: baseline (T1) and 3 weeks follow up (T2)
Change in Autonomous Motivation for Stress Management
Time frame: baseline (T1) and 3 weeks follow up (T2)
Change in Autonomous Motivation for Healthy Eating
Time frame: baseline (T1) and 3 weeks follow up (T2)
Change in Autonomous Motivation for Physical Activity
Time frame: baseline (T1) and 3 weeks follow up (T2)
Change in General Self-efficacy
Time frame: baseline (T1) and 3 weeks follow up (T2)
Change in Healthy Eating Self-efficacy
Time frame: baseline (T1) and 3 weeks follow up (T2)
Change in Physical Activity Self-efficacy
Time frame: baseline (T1) and 3 weeks follow up (T2)
Change in Emotion Regulation
Time frame: baseline (T1) and 3 weeks follow up (T2)
Change in Perceived Stress
Time frame: baseline (T1) and 3 weeks follow up (T2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mei-Wei Chang, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-oriented episodic future thinking in people with Obesity and Weight Loss, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: baseline (T1) and 3 weeks follow up (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2025.