ObesityNCT06280339
Food Cravings Strategies During Dietary Weight Loss
A study testing Test two food cravings strategies during dietary weight loss and Dietary weight loss program +Food cravings strategies in people with Obesity and Food Cravings, run by University of Illinois at Urbana-Champaign at 2 sites in United States.
Trial summary
The purpose is to optimize the EMPOWER program by integrating strategies to reduce food cravings, a critical yet often overlooked factor for long-term success in weight management. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Food Cravings, Weight Loss
- What is being tested?
- Test two food cravings strategies during dietary weight loss and Dietary weight loss program +Food cravings strategies
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jan 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult between the ages of 18 and 75
- BMI of at least 28 and above
- 4- Have access to the internet 3- Report experiencing at least a moderate amount of food cravings, and they consume the craved food at least a few times per week.
Who cannot join
- Participation in a formal weight management program within the preceding three months.
- Usage of medications impacting weight.
- Being pregnant or breastfeeding.
- Having a history of bariatric surgeries.
- Diagnosed with DM type 1 or/and Use insulin injection
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Bevier HAll UIUC
Urbana, Illinois, 61801
Nouf Alfouzan, 217-898-5480, noufa2@illinois.edu
- Recruiting
Bevier HAll UIUC
Urbana, Illinois, 61801
Nouf Alfouzan, 217-898-5480, noufa2@illinois.edu
Manabu Nakamura
About this study
Official title: Comparison of Coping Strategies to Reduce Food Cravings During Dietary Weight Loss
The purpose is to optimize the EMPOWER program by integrating strategies to reduce food cravings, a critical yet often overlooked factor for long-term success in weight management.
The objective of this study is to determine the efficacy of craving coping strategies on weight loss outcomes by conducting a randomized controlled trial. Participants will be randomized to receive one of the two strategies to manage food cravings.
Read the detailed description
Obesity is a major contributor to developing chronic diseases such as hypertension, heart disease, stroke, and diabetes, and 41.9% of adults were obese in 2020 in the United States. Although weight loss can reduce or remit these comorbidities , it is challenging for most individuals with obesity to achieve clinically significant weight loss and sustain healthy weight through dietary/lifestyle modifications. Achieving sustainable weight loss must be accompanied by dietary/lifestyle modifications that can be sustained comfortably for a lifetime. Currently, there is no dietary weight loss program that can reliably induce sustainable weight loss.
To address this deficiency, our lab has been developing a novel dietary weight loss program that can achieve a lifetime healthy weight. In our three weight loss trials, we observed that the reduction of food cravings is associated with successful weight loss and subsequent weight maintenance. Food cravings have been suggested to predict food intake and weight gain, lack of success in weight loss, and early drop-out from weight management programs, supporting our observation. Food cravings are defined as strong or intense desires for a particular type of food and have been reported to occur in approximately 58% of adults. Individuals with overweight or obesity report more frequent and intense cravings for energy-dense food, such as high-fat and sweet foods, relative to normal-weight people.
Specific food craving coping strategies are developed to reduce the frequency and intensity of cravings to minimize the risk of excessive food intake. These strategies involve cognitive-behavioral principles, including controlled-based strategies such as avoidance, resistance, and inclusion. The avoidance strategy uses behavior-oriented techniques to modify the immediate environment, teaching individuals to encourage healthy eating and avoid unhealthy eating by controlling the stimuli that trigger their behaviors. The resistance strategies focus on cognitive regulation and enhancing self-regulatory control, which teaches individuals how to cognitively restructure urges related to craved food and mentally distract themselves from cravings. The inclusion strategies focus on self-regulation and planning and aim to satisfy food cravings by strategically incorporating craved foods into balanced meals.
Despite the existence of coping strategies, very few studies evaluate the efficacy of these strategies during weight loss trials. Thus, we evaluated the relationship between weight loss outcomes and the degree of cravings using intra-cohort analysis in our two weight loss trials. Our preliminary findings suggested that effective management of food cravings appears to be a key to successful weight loss and weight maintenance. Study 1 found that better control over food cravings during weight loss and maintenance was associated with long-term success in weight loss outcomes. Study 2 demonstrated that participants who achieved clinically significant or greater weight loss (5% weight loss) had significantly lower food cravings.
Building on the findings from our preliminary studies, a specific aim of this research proposal is to determine the efficacy of craving coping strategies (and a combination of strategies) on weight loss outcomes by conducting a randomized controlled trial.
- Conditions
- Obesity, Food Cravings, Weight Loss
- Being tested
- Test two food cravings strategies during dietary weight loss, Dietary weight loss program +Food cravings strategies
- Keywords
- Food cravings, Strategies, 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.
Test two food cravings strategies during dietary weight lossBehavioural
The intervention includes 12 online nutrition education sessions using the MealPlot App to track food intake and view the daily weight charts. Participants need to weigh themselves daily using a Wi-Fi scale. Participants will complete 12 asynchronous online diet improvement sessions (eText) lasting 45 minutes each. The 12 sessions will be conducted weekly for the intervention period (12 weeks). The following four sessions will be focused on creating consistent eating and sleeping patterns related to timing, frequency, and portion, as well as daily self-monitoring of weight. After that, participants will continue to complete the rest of asynchronous online diet improvement sessions, including personalized weight loss diets from their kitchen based on their diet practice and food preference, safe and efficient weight loss, weight maintenance and healthy eating, skills to select foods and create meals that prevent overeating, all to be completed by the end of 12 weeks.
Dietary weight loss program +Food cravings strategiesBehavioural
The intervention includes 12 online nutrition education sessions using the MealPlot App to track food intake and view the daily weight charts. Participants need to weigh themselves daily using a Wi-Fi scale. Participants will complete 12 asynchronous online diet improvement sessions (eText) lasting 45 minutes each. The 12 sessions will be conducted weekly for the intervention period (12 weeks). The following four sessions will be focused on creating consistent eating and sleeping patterns related to timing, frequency, and portion, as well as daily self-monitoring of weight. After that, participants will continue to complete the rest of asynchronous online diet improvement sessions, including personalized weight loss diets from their kitchen based on their diet practice and food preference, safe and efficient weight loss, weight maintenance and healthy eating, skills to select foods and create meals that prevent overeating, all to be completed by the end of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Avoidance group | Experimental | Avoidance Strategy: This strategy focuses on teaching individuals how to modify their immediate environments to make it easier to control food cravings. Examples include redesigning your home to remove tempting foods or limiting access to craved foods. It also covers tips on making grocery lists and communicating health goals within your social circle. Additionally, it includes a toolkit for situations where controlling the immediate environment may be challenging, such as at parties or social gatherings Both strategies include educational materials explaining the definition of food cravings, factors that contribute to food cravings, and the distinction between hunger and cravings. Receives: Behavioral: Test two food cravings strategies during dietary weight loss; Behavioral: Dietary weight loss program +Food cravings strategies |
| Inclusion group | Experimental | Inclusion Strategy: This strategy teaches individuals how to modify their eating habits by paying attention to the portion size of craved foods and incorporating them into well-balanced meals, avoiding eating between meals. It also includes a toolkit for situations where individuals may struggle to include craved foods in their balanced meals.
Both strategies include educational materials explaining the definition of food cravings, factors that contribute to food cravings, and the distinction between hunger and cravings. Receives: Behavioral: Test two food cravings strategies during dietary weight loss; Behavioral: Dietary weight loss program +Food cravings strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight in kilograms measured on a standard scale
Measured: Change from baseline (0 month) to 3 month
Food Craving Strategies Compliance
Bi-weekly questionnaires will be utilized to assess adherence to the strategies and the state of food cravings.
The state of food cravings will be measured using a visual analog scale.
Adherence to the strategies will be assessed using a Likert scale based on three areas:
- Difficulty of implementing the strategies, ranging from '1=Very difficult' to '5=Not difficult'.
- The frequency of using the strategies ranges from '1=Never' to '5=Every day'.
- Effectiveness of the strategies in managing food cravings, ranging from '1=Not helpful' to '5=Very helpful'.
Measured: Change from baseline 0 week to 12 week runs-bi-weekly
Food Cravings
The Food Cravings Questionnaire-Trait (FCQ-T) evaluates craving traits through 39 statements. Respondents use a Likert scale ranging from 1, "Never" or "Not Applicable" (NA), to 6, "Always" or "Almost every day".
Measured: Change from baseline 0 week to 6 week and week 12
Food Cravings
The Food Craving Inventory (FCI) assesses the frequency of food cravings based on 28 food items. Participants rate the frequency of their cravings using a Likert scale ranging from 1, "Never", to 5, "Always" or "Almost every day".
Measured: Change from baseline 0 week to 6 week and week 12
Secondary outcomes (1)
Dietary intake
The Automated Self-Administered 24-hour (ASA24®) is an online tool to assess 24-hour dietary intake.
Measured: Baseline. month 1, month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start29 Jan 2024
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be enrolled in dietary weight loss program. Before the first meeting they will be randomized to one of the two study groups that focus on teaching participants different strategies to cope with food cravings (Inclusion vs. Avoidance).. To ensure balanced representation and meaningful study results, the randomization process will consider specific characteristics, including BMI category, sex, and age. This stratified randomization method helps us compare the effects of the intervention between different groups of participants.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280339
- Sponsor's protocol ID
- IRB23-0190
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stierman B, Afful J, Carroll MD, Chen TC, Davy O, Fink S, Fryar CD, Gu Q, Hales CM, Hughes JP, Ostchega Y, Storandt RJ, Akinbami LJ. National Health and Nutrition Examination Survey 2017-March 2020 Prepandemic Data Files-Development of Files and Prevalence Estimates for Selected Health Outcomes. Natl Health Stat Report. 2021 Jun 14;(158):10.15620/cdc:106273. doi: 10.15620/cdc:106273.
PubMed 39380201American College of Cardiology/American Heart Association Task Force on Practice Guidelines, Obesity Expert Panel, 2013. Executive summary: Guidelines (2013) for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Obesity Society published by the Obesity Society and American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Based on a systematic review from the The Obesity Expert Panel, 2013. Obesity (Silver Spring). 2014 Jul;22 Suppl 2:S5-39. doi: 10.1002/oby.20821. No abstract available.
PubMed 24961825Butryn ML, Webb V, Wadden TA. Behavioral treatment of obesity. Psychiatr Clin North Am. 2011 Dec;34(4):841-59. doi: 10.1016/j.psc.2011.08.006.
PubMed 22098808Gardner CD, Kiazand A, Alhassan S, Kim S, Stafford RS, Balise RR, Kraemer HC, King AC. Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A TO Z Weight Loss Study: a randomized trial. JAMA. 2007 Mar 7;297(9):969-77. doi: 10.1001/jama.297.9.969.
PubMed 17341711Finley CE, Barlow CE, Greenway FL, Rock CL, Rolls BJ, Blair SN. Retention rates and weight loss in a commercial weight loss program. Int J Obes (Lond). 2007 Feb;31(2):292-8. doi: 10.1038/sj.ijo.0803395. Epub 2006 Jun 6.
PubMed 16755283Lee MH, Applegate CC, Shaffer AL, Emamaddin A, Erdman JW Jr, Nakamura MT. A feasibility study to test a novel approach to dietary weight loss with a focus on assisting informed decision making in food selection. PLoS One. 2022 May 26;17(5):e0267876. doi: 10.1371/journal.pone.0267876. eCollection 2022.
PubMed 35617305Boswell RG, Kober H. Food cue reactivity and craving predict eating and weight gain: a meta-analytic review. Obes Rev. 2016 Feb;17(2):159-77. doi: 10.1111/obr.12354. Epub 2015 Dec 8.
PubMed 26644270Hill AJ. The psychology of food craving. Proc Nutr Soc. 2007 May;66(2):277-85. doi: 10.1017/S0029665107005502.
PubMed 17466108Jakubowicz D, Froy O, Wainstein J, Boaz M. Meal timing and composition influence ghrelin levels, appetite scores and weight loss maintenance in overweight and obese adults. Steroids. 2012 Mar 10;77(4):323-31. doi: 10.1016/j.steroids.2011.12.006. Epub 2011 Dec 9.
PubMed 22178258Hill AJ, Weaver CF, Blundell JE. Food craving, dietary restraint and mood. Appetite. 1991 Dec;17(3):187-97. doi: 10.1016/0195-6663(91)90021-j.
PubMed 1799281Weingarten HP, Elston D. Food cravings in a college population. Appetite. 1991 Dec;17(3):167-75. doi: 10.1016/0195-6663(91)90019-o.
PubMed 1799279White MA, Whisenhunt BL, Williamson DA, Greenway FL, Netemeyer RG. Development and validation of the food-craving inventory. Obes Res. 2002 Feb;10(2):107-14. doi: 10.1038/oby.2002.17.
PubMed 11836456Gendall KA, Joyce PR, Sullivan PF. Impact of definition on prevalence of food cravings in a random sample of young women. Appetite. 1997 Feb;28(1):63-72. doi: 10.1006/appe.1996.0060.
PubMed 9134095Chao AM, Jastreboff AM, White MA, Grilo CM, Sinha R. Stress, cortisol, and other appetite-related hormones: Prospective prediction of 6-month changes in food cravings and weight. Obesity (Silver Spring). 2017 Apr;25(4):713-720. doi: 10.1002/oby.21790.
PubMed 28349668Gilhooly CH, Das SK, Golden JK, McCrory MA, Dallal GE, Saltzman E, Kramer FM, Roberts SB. Food cravings and energy regulation: the characteristics of craved foods and their relationship with eating behaviors and weight change during 6 months of dietary energy restriction. Int J Obes (Lond). 2007 Dec;31(12):1849-58. doi: 10.1038/sj.ijo.0803672. Epub 2007 Jun 26.
PubMed 17593902
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Coping Strategies to Reduce Food Cravings During Dietary Weight Loss
- ClinicalTrials.gov ID
- NCT06280339
- Acronym / sponsor ID
- IRB23-0190
- Conditions
- Obesity, Food Cravings, Weight Loss
- Keywords
- Food cravings, Strategies, Weight loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to optimize the EMPOWER program by integrating strategies to reduce food cravings, a critical yet often overlooked factor for long-term success in weight management.
The objective of this study is to determine the efficacy of craving coping strategies on weight loss outcomes by conducting a randomized controlled trial. Participants will be randomized to receive one of the two strategies to manage food cravings.
Detailed description
Obesity is a major contributor to developing chronic diseases such as hypertension, heart disease, stroke, and diabetes, and 41.9% of adults were obese in 2020 in the United States. Although weight loss can reduce or remit these comorbidities , it is challenging for most individuals with obesity to achieve clinically significant weight loss and sustain healthy weight through dietary/lifestyle modifications. Achieving sustainable weight loss must be accompanied by dietary/lifestyle modifications that can be sustained comfortably for a lifetime. Currently, there is no dietary weight loss program that can reliably induce sustainable weight loss.
To address this deficiency, our lab has been developing a novel dietary weight loss program that can achieve a lifetime healthy weight. In our three weight loss trials, we observed that the reduction of food cravings is associated with successful weight loss and subsequent weight maintenance. Food cravings have been suggested to predict food intake and weight gain, lack of success in weight loss, and early drop-out from weight management programs, supporting our observation. Food cravings are defined as strong or intense desires for a particular type of food and have been reported to occur in approximately 58% of adults. Individuals with overweight or obesity report more frequent and intense cravings for energy-dense food, such as high-fat and sweet foods, relative to normal-weight people.
Specific food craving coping strategies are developed to reduce the frequency and intensity of cravings to minimize the risk of excessive food intake. These strategies involve cognitive-behavioral principles, including controlled-based strategies such as avoidance, resistance, and inclusion. The avoidance strategy uses behavior-oriented techniques to modify the immediate environment, teaching individuals to encourage healthy eating and avoid unhealthy eating by controlling the stimuli that trigger their behaviors. The resistance strategies focus on cognitive regulation and enhancing self-regulatory control, which teaches individuals how to cognitively restructure urges related to craved food and mentally distract themselves from cravings. The inclusion strategies focus on self-regulation and planning and aim to satisfy food cravings by strategically incorporating craved foods into balanced meals.
Despite the existence of coping strategies, very few studies evaluate the efficacy of these strategies during weight loss trials. Thus, we evaluated the relationship between weight loss outcomes and the degree of cravings using intra-cohort analysis in our two weight loss trials. Our preliminary findings suggested that effective management of food cravings appears to be a key to successful weight loss and weight maintenance. Study 1 found that better control over food cravings during weight loss and maintenance was associated with long-term success in weight loss outcomes. Study 2 demonstrated that participants who achieved clinically significant or greater weight loss (5% weight loss) had significantly lower food cravings.
Building on the findings from our preliminary studies, a specific aim of this research proposal is to determine the efficacy of craving coping strategies (and a combination of strategies) on weight loss outcomes by conducting a randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be enrolled in dietary weight loss program. Before the first meeting they will be randomized to one of the two study groups that focus on teaching participants different strategies to cope with food cravings (Inclusion vs. Avoidance).. To ensure balanced representation and meaningful study results, the randomization process will consider specific characteristics, including BMI category, sex, and age. This stratified randomization method helps us compare the effects of the intervention between different groups of participants.
| Arm | Type | Receives |
|---|---|---|
| Avoidance group | Experimental | Behavioral: Test two food cravings strategies during dietary weight loss, Behavioral: Dietary weight loss program +Food cravings strategiesAvoidance Strategy: This strategy focuses on teaching individuals how to modify their immediate environments to make it easier to control food cravings. Examples include redesigning your home to remove tempting foods or limiting access to craved foods. It also covers tips on making grocery lists and communicating health goals within your social circle. Additionally, it includes a toolkit for situations where controlling the immediate environment may be challenging, such as at parties or social gatherings Both strategies include educational materials explaining the definition of food cravings, factors that contribute to food cravings, and the distinction between hunger and cravings. |
| Inclusion group | Experimental | Behavioral: Test two food cravings strategies during dietary weight loss, Behavioral: Dietary weight loss program +Food cravings strategiesInclusion Strategy: This strategy teaches individuals how to modify their eating habits by paying attention to the portion size of craved foods and incorporating them into well-balanced meals, avoiding eating between meals. It also includes a toolkit for situations where individuals may struggle to include craved foods in their balanced meals. Both strategies include educational materials explaining the definition of food cravings, factors that contribute to food cravings, and the distinction between hunger and cravings. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult between the ages of 18 and 75
- BMI of at least 28 and above
- 4- Have access to the internet 3- Report experiencing at least a moderate amount of food cravings, and they consume the craved food at least a few times per week.
Key exclusion criteria (5 listed)
- Participation in a formal weight management program within the preceding three months.
- Usage of medications impacting weight.
- Being pregnant or breastfeeding.
- Having a history of bariatric surgeries.
- Diagnosed with DM type 1 or/and Use insulin injection
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 |
|---|---|---|
| Test two food cravings strategies during dietary weight lossThe intervention includes 12 online nutrition education sessions using the MealPlot App to track food intake and view the daily weight charts. Participants need to weigh themselves daily using a Wi-Fi scale. Participants will complete 12 asynchronous online diet improvement sessions (eText) lasting 45 minutes each. The 12 sessions will be conducted weekly for the intervention period (12 weeks). The following four sessions will be focused on creating consistent eating and sleeping patterns related to timing, frequency, and portion, as well as daily self-monitoring of weight. After that, participants will continue to complete the rest of asynchronous online diet improvement sessions, including personalized weight loss diets from their kitchen based on their diet practice and food preference, safe and efficient weight loss, weight maintenance and healthy eating, skills to select foods and create meals that prevent overeating, all to be completed by the end of 12 weeks. | Behavioural | Avoidance group, Inclusion group |
| Dietary weight loss program +Food cravings strategiesThe intervention includes 12 online nutrition education sessions using the MealPlot App to track food intake and view the daily weight charts. Participants need to weigh themselves daily using a Wi-Fi scale. Participants will complete 12 asynchronous online diet improvement sessions (eText) lasting 45 minutes each. The 12 sessions will be conducted weekly for the intervention period (12 weeks). The following four sessions will be focused on creating consistent eating and sleeping patterns related to timing, frequency, and portion, as well as daily self-monitoring of weight. After that, participants will continue to complete the rest of asynchronous online diet improvement sessions, including personalized weight loss diets from their kitchen based on their diet practice and food preference, safe and efficient weight loss, weight maintenance and healthy eating, skills to select foods and create meals that prevent overeating, all to be completed by the end of 12 weeks. | Behavioural | Avoidance group, Inclusion group |
Primary outcome
Body weight
Time frame: Change from baseline (0 month) to 3 month
Body weight in kilograms measured on a standard scale
Food Craving Strategies Compliance
Time frame: Change from baseline 0 week to 12 week runs-bi-weekly
Bi-weekly questionnaires will be utilized to assess adherence to the strategies and the state of food cravings. The state of food cravings will be measured using a visual analog scale. Adherence to the strategies will be assessed using a Likert scale based on three areas: 1. Difficulty of implementing the strategies, ranging from '1=Very difficult' to '5=Not difficult'. 2. The frequency of using the strategies ranges from '1=Never' to '5=Every day'. 3. Effectiveness of the strategies in managing food cravings, ranging from '1=Not helpful' to '5=Very helpful'.
Food Cravings
Time frame: Change from baseline 0 week to 6 week and week 12
The Food Cravings Questionnaire-Trait (FCQ-T) evaluates craving traits through 39 statements. Respondents use a Likert scale ranging from 1, "Never" or "Not Applicable" (NA), to 6, "Always" or "Almost every day".
Food Cravings
Time frame: Change from baseline 0 week to 6 week and week 12
The Food Craving Inventory (FCI) assesses the frequency of food cravings based on 28 food items. Participants rate the frequency of their cravings using a Likert scale ranging from 1, "Never", to 5, "Always" or "Almost every day".
1 secondary outcome
Dietary intake
Time frame: Baseline. month 1, month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Background: PubMed 39380201Stierman B, Afful J, Carroll MD, Chen TC, Davy O, Fink S, Fryar CD, Gu Q, Hales CM, Hughes JP, Ostchega Y, Storandt RJ, Akinbami LJ. National Health and Nutrition Examination Survey 2017-March 2020 Prepandemic Data Files-Development of Files and Prevalence Estimates for Selected Health Outcomes. Natl Health Stat Report. 2021 Jun 14;(158):10.15620/cdc:106273. doi: 10.15620/cdc:106273.
- Background: PubMed 24961825American College of Cardiology/American Heart Association Task Force on Practice Guidelines, Obesity Expert Panel, 2013. Executive summary: Guidelines (2013) for the management of overweight and obesity in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Obesity Society published by the Obesity Society and American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Based on a systematic review from the The Obesity Expert Panel, 2013. Obesity (Silver Spring). 2014 Jul;22 Suppl 2:S5-39. doi: 10.1002/oby.20821. No abstract available.
- Background: PubMed 22098808Butryn ML, Webb V, Wadden TA. Behavioral treatment of obesity. Psychiatr Clin North Am. 2011 Dec;34(4):841-59. doi: 10.1016/j.psc.2011.08.006.
- Background: PubMed 17341711Gardner CD, Kiazand A, Alhassan S, Kim S, Stafford RS, Balise RR, Kraemer HC, King AC. Comparison of the Atkins, Zone, Ornish, and LEARN diets for change in weight and related risk factors among overweight premenopausal women: the A TO Z Weight Loss Study: a randomized trial. JAMA. 2007 Mar 7;297(9):969-77. doi: 10.1001/jama.297.9.969.
- Background: PubMed 16755283Finley CE, Barlow CE, Greenway FL, Rock CL, Rolls BJ, Blair SN. Retention rates and weight loss in a commercial weight loss program. Int J Obes (Lond). 2007 Feb;31(2):292-8. doi: 10.1038/sj.ijo.0803395. Epub 2006 Jun 6.
- Background: PubMed 35617305Lee MH, Applegate CC, Shaffer AL, Emamaddin A, Erdman JW Jr, Nakamura MT. A feasibility study to test a novel approach to dietary weight loss with a focus on assisting informed decision making in food selection. PLoS One. 2022 May 26;17(5):e0267876. doi: 10.1371/journal.pone.0267876. eCollection 2022.
- Background: PubMed 26644270Boswell RG, Kober H. Food cue reactivity and craving predict eating and weight gain: a meta-analytic review. Obes Rev. 2016 Feb;17(2):159-77. doi: 10.1111/obr.12354. Epub 2015 Dec 8.
- Background: PubMed 17466108Hill AJ. The psychology of food craving. Proc Nutr Soc. 2007 May;66(2):277-85. doi: 10.1017/S0029665107005502.
- Background: PubMed 22178258Jakubowicz D, Froy O, Wainstein J, Boaz M. Meal timing and composition influence ghrelin levels, appetite scores and weight loss maintenance in overweight and obese adults. Steroids. 2012 Mar 10;77(4):323-31. doi: 10.1016/j.steroids.2011.12.006. Epub 2011 Dec 9.
- Background: PubMed 1799281Hill AJ, Weaver CF, Blundell JE. Food craving, dietary restraint and mood. Appetite. 1991 Dec;17(3):187-97. doi: 10.1016/0195-6663(91)90021-j.
- Background: PubMed 1799279Weingarten HP, Elston D. Food cravings in a college population. Appetite. 1991 Dec;17(3):167-75. doi: 10.1016/0195-6663(91)90019-o.
- Background: PubMed 11836456White MA, Whisenhunt BL, Williamson DA, Greenway FL, Netemeyer RG. Development and validation of the food-craving inventory. Obes Res. 2002 Feb;10(2):107-14. doi: 10.1038/oby.2002.17.
- Individual participant dataSharing planned: Undecided
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Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test two food cravings strategies during dietary weight loss and Dietary weight loss program +Food cravings strategies in people with Obesity and Food Cravings, run by University of Illinois at Urbana-Champaign at 2 sites 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manabu Nakamura, PhD (217-333-1267, mtnakamu@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Change from baseline (0 month) to 3 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06280339, which also lists 18 linked publications.
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 28 Feb 2024.